As filed with the Commission on April 17, 2024

Registration No. 333-276987

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT NO. 2

TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

INVIZYNE TECHNOLOGIES INC.

(Exact name of registrant as specified in its charter)

750 Royal Oaks Drive, Suite 106

Monrovia, CA 91016

(626) 415-1488

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Michael Heltzen

Chief Executive Officer

Invizyne Technologies Inc.

750 Royal Oaks Drive, Suite 106

Monrovia, CA 91016

(626) 415-1488

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☒

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

EXPLANATORY NOTE

This registration statement contains two forms of prospectus, as set forth below.

The Public Offering Prospectus and the Security Holder Prospectus will be identical in all respects, except for the following principal parts which will detail the securities of and offering by the Selling Security Holders:

The registrant has included in this registration statement, after the financial statements, a set of alternate pages to reflect the foregoing differences between the Public Offering Prospectus and the Security Holder Prospectus. The Public Offering Prospectus will exclude the alternate pages and will be used for the public offering by the Registrant. The Security Holder Prospectus will be substantively identical to the Public Offering Prospectus, except for the addition or substitution of the alternate pages and will be used for the resale offering by the Selling Security Holder.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

PROSPECTUS

Subject to Completion, Dated April 17, 2024

Invizyne TECHNOLOGIES INC.

4,300,000 SHARES OF COMMON STOCK

Invizyne Technologies Inc. (the “Company,” “we,” “us” and “our”) is offering 4,300,000 shares of its common stock, par value $0.000001 (“Common Stock”), at a price per share of $4.00, in its initial public offering. The public offering price of the Common Stock was determined through negotiation between the underwriter and us, and the offering price used throughout this prospectus may not be indicative of the price of a share of Common Stock in the market after the initial public offering.

The underwriter, in its sale of the shares being purchased from the Company, intends to give preference to holders of MDB Capital Holdings, LLC (“MDB”) Class A Shares, after which it will give preference to other beneficial shareholders of MDB and then of the Company. To the extent these foregoing groups do not purchase all the available shares, including the overallotment, then shares will be sold to other persons making an indication for purchase of shares through their respective brokers or dealers.

MDB is the majority holder of our Common Stock, beneficially holding 8,272,851 shares of our Common Stock, representing 62.88% of our issued and outstanding shares of Common Stock prior to this offering. As such, MDB is the parent company of Invizyne prior to this offering. Additionally, Messrs. Christopher Marlett, Anthony DiGiandomenico are majority shareholders and directors of MDB, and directors of the Company. Mr. Mo Hayat, the Chairman of the Board and President of the Company, also is the Chief of Entrepreneurship & Operations of MDB.

We have engaged Public Ventures, LLC, or Public Ventures, as the underwriter. Public Ventures is a wholly owned subsidiary of MDB and an affiliate of the Company.

Public Ventures and MDB both have a “conflict of interest” with the Company under Rule 5121 of the Financial Industry Regulatory Authority, Inc., or FINRA. Accordingly, Digital Offering LLC has agreed to act as a “qualified independent underwriter” within the meaning of FINRA Rule 5121 in connection with this offering. In its role as a qualified independent underwriter, Digital Offering LLC has participated in the preparation of this registration statement and the prospectus and has exercised the usual standards of due diligence with respect thereto. For a more complete discussion of the role and compensation of the underwriter, please see the section of this prospectus entitled “Underwriting (Conflicts of Interest).”

Prior to this offering, there has been no public market for our Common Stock. We intend to apply to list our Common Stock on The Nasdaq Capital Market, sometimes referred to as Nasdaq, under the symbol “IZTC.” No assurance can be given that our application will be approved or that an active trading market for our Common Stock will develop. Approval of our shares of Common Stock to be listed on Nasdaq is a closing condition of this offering under our agreement with the underwriter.

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012. As such, in this prospectus we have taken advantage of certain reduced disclosure obligations that apply to emerging growth companies regarding selected financial data and executive compensation arrangements. See “Prospectus Summary— Implications of Being an Emerging Growth Company.”

Investing in our securities involves a high degree of risk. See “Risk Factors” beginning on page 9 of this prospectus to read about factors you should consider before deciding to invest in our securities.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

We have granted a 45-day option to the underwriter to purchase up to 645,000 [15%] additional shares of Common Stock solely to cover over-allotments, if any. If the underwriter exercises the option in full, the total underwriting discounts and commissions payable will be $989,000 and the total proceeds to us, before expenses, will be $18,791,000.

The underwriter expects to deliver the shares to purchasers on or about                   , 2024.

PUBLIC VENTURES, LLC

The date of this prospectus is                   , 2024

TABLE OF CONTENTS

Neither we nor the underwriter have authorized anyone to provide information different from that contained in this prospectus, any amendment or supplement to this prospectus or in any free writing prospectus prepared by us or on our behalf. Neither we nor the underwriter take any responsibility for, and can provide no assurance as to the reliability of, any information other than the information in this prospectus, any amendment or supplement to this prospectus, and any free writing prospectus prepared by us or on our behalf. Neither the delivery of this prospectus nor the sale of the shares of Common Stock means that information contained in this prospectus is correct after the date of this prospectus. This prospectus is not an offer to sell or the solicitation of an offer to buy the shares of Common Stock in any circumstances under which such offer or solicitation is unlawful.

You should rely only on the information contained in this prospectus and any free writing prospectus prepared by or on behalf of us or to which we have referred you. Neither we nor the underwriter have authorized anyone to provide you with information that is different. We and the underwriter are offering to sell the shares of Common Stock, and seeking offers to buy the shares of Common Stock, only in jurisdictions where offers and sales are permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of the shares of Common Stock.

For investors outside of the United States: Neither we nor the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to this offering and the distribution of this prospectus outside the United States.

ABOUT THIS PROSPECTUS

Please read this prospectus carefully. It describes our business, our financial condition and results of operations. We have prepared this prospectus so that you will have the information necessary to make an informed investment decision.

This prospectus includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We believe that the data obtained from these industry publications and third-party research, surveys and studies are reliable. We are ultimately responsible for all the disclosures included in this prospectus.

We note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to the registration statement of which this prospectus is a part were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

Some of our trademarks and trade names are used in this prospectus, which are intellectual property owned by the Company. This prospectus also includes trademarks, trade names, and service marks that are the property of other organizations. Our trademarks and trade names referred to in this prospectus may appear without the TM symbol or other symbols indicating registration of the symbol, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and trade names.

The share numbers and financial data relating to the number of shares issued and outstanding have been adjusted to account for the share dividend of 6,483,351 shares at the rate of 1.0775673 shares for each issued and outstanding share of Common Stock, declared and paid on February 7, 2024. Immediately after the dividend, there are 12,500,000 shares of Common Stock issued and outstanding.

PROSPECTUS SUMMARY

This summary highlights selected information that is presented in greater detail elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our Common Stock. You should carefully read this prospectus in its entirety before investing in our Common Stock, including the sections titled “Risk Factors,” “Special Note Regarding Forward-Looking Statements,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our consolidated financial statements and the accompanying notes, provided elsewhere in this prospectus. Some of the statements in this prospectus constitute forward-looking statements. See the section titled “Special Note Regarding Forward-Looking Statements.”

The words “Invizyne,” “us,” “we,” the “Company,” and any variants thereof used herein refer to Invizyne Technologies Inc. and our consolidated subsidiary.

Overview

Invizyne believes it has discovered and is developing a process that could significantly change biomanufacturing by means of leveraging cell-free multi-step enzyme-based systems that will be able to efficiently transform natural or renewable resources into sought after chemicals. We believe that our biomanufacturing platform, known as SimplePath™, will be an important alternative to the current methods of chemical compound production, which methods today are generally chemical synthesis, natural extraction, and synthetic biology. Our objective with SimplePath™ is to enable the efficient production of a diverse range of select chemicals that are used in pharmaceuticals, fuels, materials, food additives, for example. We believe that SimplePath™ not only can maximize the value of these chemicals but also will contribute to the development of novel chemical compounds that should open new markets and business opportunities.

Invizyne was established in 2019, and is a pre-revenue, development stage company. Our primary operational activities to date have been development of the SimplePath™ platform. Application of the platform and the range and type of potential products are largely still in the development stage. We have only produced certain potential products in a laboratory setting, producing only laboratory quantities. As such the platform has not been tested in terms of broader market acceptance or manufacturing both at introductory and commercial levels. Whether or not we can commercialize our platform and whether or not the potential products we currently have determined possible with the platform can be manufactured and sold at commercial levels, at this stage, is uncertain.

Our SimplePath™ Platform

Our SimplePath™ platform consists of a series of enzyme based biomanufacturing systems that leverage natural processes to perform complex chemical conversions that convert a starting material into a desired end-product. Each SimplePath™ system is composed of one or more “modules” which consist of one or more enzymes that work together to perform a defined biocatalytic conversion. While a module can operate independently, multiple modules can be coupled and designed to work together in a defined sequence. This sequencing of enzymatic steps is referred to as a “cascade” or an “enzyme cascade”. Each SimplePath™ system is comprised of several key parts (i.e. substrate(s) (the substance on which an enzyme acts), enzymes, cofactors (a substance, other than the substrate, whose presence is essential for the activity of an enzyme), defined operating conditions, selected purification processes, and other system specific elements) that act together to produce one or more intended products.

The roots of the SimplePath™ platform trace back to a more than decade-long research endeavor at Professor James Bowie’s laboratory at UCLA, where the core innovations underlying the SimplePath™ platform were developed.

One of the most common methods of synthesizing new molecules is chemical synthesis. Chemical synthesis is the construction of complex chemical compounds from simpler ones. It is applied to all types of chemical compounds. This process is often expensive and environmentally damaging or polluting. Energy use, which is usually high in this process, is often a factor in determining the viability of making an end-product. Most chemical synthesis methods also produce significant waste and often use petroleum-derived chemicals to derive the end-product. Side products can be difficult to separate from the main product; although some by-products are welcomed if they have their own commercial viability. Chemical synthesis, also, may have long and complex production cycles.

Natural extraction, another common method of sourcing molecules, typically is inefficient, especially when the desired molecule is only found in small concentrations in a plant or other organism. Natural extraction processes can use large amounts of energy when compared to the end result achieved. Often, environmentally damaging solvents are used in the extraction process. Traditional methods of natural extraction typically generate substantial amounts of waste product, which presents issues of local pollution and waste management. There is often an issue of the purity of the end-product, and in many instances the purification process will damage or destroy the active agent being sought. Achieving industrial quantity is an issue in natural extraction. Using natural resources, such as plants, may actually result in over harvesting with consequences to biodiversity, damaging land resources, and local income and related societal issues.

Synthetic biology, another form of synthesizing new molecules, seeks to rewire a unicellular organism, such as yeast, using genetic engineering to produce the desired molecule end-product. This approach has some benefits over the other two methods mentioned above, but it has been more difficult than originally thought to realize the sought after end-product in a timely fashion and at a reasonable cost. The desired molecule using this method, is often toxic to the organism, especially as concentrations increase; as a result molecule yields tend to be low given competing processes within the organism. The intricate interactions and regulatory networks within cells (in essence, the complex and often interdependent series of control systems that orchestrate activities within a cell) make it difficult to predict and optimize the desired outcomes. There tend to be issues achieving long term yield and productivity using synthetic biology when production is scaled up and subjected to industrial conditions.

Companies working in the biobased industry are addressing the world’s environmentally and socioeconomically unsustainable dependence on petroleum, still the key feedstock, which is the raw material used to produce the final product, for a wide array of products. Developing chemical the raw material feedstocks from renewable sources and using catalytic chemistry to create high-value chemicals that replace petrochemical products, among others, is critical to help achieve global sustainability. Biofuels are a major focus of the biobased industry. The biobased industry, however, is expanding into additional sectors, such as agriculture, products using acrylic acid, food production and safety, cleaning products, lubricants, detergents, fertilizers and many other chemicals in common use today. Researchers and firms are increasingly focusing on the development, production and commercialization of bio-derived replacements for many basic chemicals that are commonly used in many industries. These replacements may even be “drop-in” direct substitutes for their petroleum-derived counterparts.

Invizyne believes it is developing a new technology process that we believe has the potential to change the way molecules are created in the future. In our laboratory, for the limited number of molecules that we have worked with to date, we believe our SimplePath™ platform performs the same conversions targeted by other cell engineering technologies. We believe that instead of using whole organisms to make biobased molecules, our platform uses only the specific enzymes that are involved in the multi-step biocatalytic process of making the molecule of interest. This discovery and understanding appears to simplify the biobased process of synthesizing a new molecule and eliminates many of the inherent limitations and bottlenecks of the legacy technologies. Although not yet tested by independent third parties, we believe for many products, the SimplePath™ platform and processes can be more efficient, less environmentally damaging or polluting, and more cost-effective than traditional methods, depending on the product that is being made. Although not yet achieved, based on our laboratory results, we also believe SimplePath™ is more predictable and can be scalable. We believe our technology has the potential to create the next generation of innovative biomanufacturing systems that leverage the power of enzymes, which we call Biomanufacturing 2.0.

We estimate that the potential applications of the SimplePath™ platform are many in addition to those that we are studying at present. In the pharmaceutical space, the platform could be used to produce new drugs. In the biofuel space, it could be used to produce cleaner and more efficient fuels. In the food space, it could be used to create new flavors and fragrances. In the industrials space, it could be used to produce less environmentally damaging or polluting and more sustainable industrial chemicals. Invizyne currently has focused its development efforts on two platform areas: pharmaceutical drug discovery and biofuels. In the drug discovery space, the Company is currently working to produce CBGA, the “mother cannabinoid” from which other cannabinoids are derived, along with other select downstream cannabinoids which could have potential applications as therapeutics. In the biofuel space, Invizyne is working to produce isobutanol, a four-carbon alcohol with a branched structure that can be used as a biofuel or as a building block to higher value downstream molecules.

Through our research and development, we believe that we have successfully demonstrated, in the laboratory setting, the feasibility of manufacturing chemicals using our SimplePath™ processes. On the basis of these achievements, we believe our processes can be scaled up to achieve commercial production capabilities. Once there is indication of proven manufacturing processes at commercial scale, for a particular chemical or set of chemicals, we believe that we will be able to enter the market to offer processes that will be able to meet the growing demand for sustainable, high-quality, chemical products.

Research and Development Grants

We have received US government grants, particularly from the Department of Energy (DOE) for work related to isobutanol, upgrading alcohols, and cofactor development, and the National Institutes of Health (NIH), for work relating to cannabinoids. This funding has enabled us to advance our technology, to conduct research, to help us validate our processes, and to move forward the boundaries of scientific and technological advancement in our field. We also have received grants from two non-government sources. To date, the grants have together totaled $12,739,318, since inception.

Commercialization Strategy

Our current, primary commercialization strategy is to collaborate with third parties to engage in aspects of product research, testing, marketing, manufacturing, and product distribution. Such collaborations will involve out-licensing our technologies. We believe that using such a commercialization strategy will allow us to reduce our capital requirements and accelerate development and market acceptance and development of the SimplePath™ platform and processes. However, such a strategy will require us to locate and enter into advantageous agreements and maintain a collaboration relationship where we will likely have to continue to provide research and development and actively maintain and protect our patents and other intellectual property or obtain the use of intellectual property rights held by third parties. There is no assurance that this marketing strategy will achieve the results that we seek or that they will be maintained.

Summary of Risk Factors

Our business is subject to a number of risks and uncertainties, including those risks discussed at length under the heading “Risk Factors” starting on page 9 hereof. These risks include risks in addition to those that are briefly noted below. Investing in our Company and its securities involves a high degree of risk. The following is a summary of some of the principal risks we face.

Below is a list of the more significant risk factors that an investor should evaluate and consider before making an investment in the Common Stock of the Company. It is a development stage company with only a limited operating history on which investors will be able to evaluate an investment in the Common Stock.

- Invizyne has not generated any significant revenues to date, and therefore may not be able to sustain its operations or become profitable in the future. Invizyne is a pre-revenue, development stage company.

- The Company anticipates that it will need additional funding in the future to continue to develop its business plan. The funds of this offering are expected to fund operations for 12 to 24 months. The independent accountants to the Company have issued their report with a going concern statement. We will explore future financing arrangements for the Company as a whole and financing specific segments of our business by using additional private and public offerings of our securities, borrowings, spinouts, joint ventures, licensing, asset sales and merger transactions.

- The synthetic biological platform being developed by the Company may not be able to develop a pipeline of commercial products, and commercial products may not be adopted by clients in the intended markets due to the novelty and complexity of the technologies involved.

- We do not have any sales, marketing, manufacturing and distribution capabilities or arrangements, and will need to create these as we move towards commercialization of our products.

- There may be regulatory hurdles that will have to be satisfied before the bio-synthesized compounds, which are the end products of the platform, can be marketed and commercially used.

- Because of the unique aspects of our synthetic biological platform, the Company is highly dependent on retaining the scientific staff and being able to hire additional scientific and related managerial staff.

- Although we have successfully achieved the production of products in the laboratory, conditions in the laboratory setting may not be reproduced in a commercial setting. If we cannot move products to a commercial scale production, our business will be harmed.

- Our processes rely on the need for purified enzymes and co-factors, which are energy molecules, such as ATP (adenosine triphosphate, which is a molecule that stores and releases energy in cells) or NADPH (nicotinamide adenine dinucleotide phosphate, which is a molecule that is an essential electron donor and provides the reducing power for anabolic reactions and redox balance), that power biocatalytic conversions, for the conversions of input feedstock, which is the raw materials used to produce a product, into final products. We will need to find competitively priced sources of these inputs for our process to be cost competitive and/or develop methods to use these resources efficiently.

- Currently, our business is highly dependent on a small number of products, which are based on our principal technology. If these products cannot be fully commercialized or are not accepted in the market, we will have expended significant financial, development and corporate assets that will not necessarily be recovered.

- Collaborations of various sorts, by our partner companies, such as with respect to research, testing, manufacturing and distribution, will be important to our business. The inability to enter into collaboration arrangements as needed, or if such collaborations are not successful, may adversely impact our business.

- There is extensive competition that we will face from legacy processes and other companies seeking to use bio-manufacturing and enzyme pathways to develop products alternative to traditional chemicals and petroleum based products.

- If we are unable to protect the intellectual property used in our technology platform and products, others may be able to copy our innovations which may impair our ability to compete effectively in our markets.

- If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third-parties, we could lose license rights that are important to our business.

- If we or our licensors are unable to protect our/their intellectual property, then our financial condition, results of operations and the value of our technology and products could be adversely affected.

- We will incur increased costs as a result of operating as a public company, and our board of directors will be required to devote substantial time to oversight of new compliance requirements and corporate governance practices.

- We are an “emerging growth company” under the JOBS Act and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our Common Stock less attractive to investors. Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it. 

- We also are a smaller reporting company within the meaning of the Securities Act of 1933, as amended, or the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to smaller reporting companies, this could make our securities less attractive to investors and may make it more difficult to compare our performance with other public companies.

- Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 until we are no longer an “emerging growth company” which will be for up to five years after this offering.

- Certain recent initial public offerings of companies with relatively small public floats have experienced extreme volatility that was seemingly unrelated to the underlying performance of the company. Our Common Stock may potentially experience rapid and substantial price volatility, and price decline, which may make it difficult for prospective investors to assess what we believe to be the value of our Common Stock.

- Concentration of ownership among our existing executive officers, directors and significant stockholders may prevent new investors from influencing significant corporate decisions.

- The price of our Common Stock may have little or no relationship to the historical sales price of our capital stock in our private placement transactions to date. The initial public offering price was determined by our management and the management of our affiliates, including the underwriter.

- Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our Common Stock.

-We may allocate the net proceeds from this offering in ways that differ from the estimates discussed in the section titled “Use of Proceeds” and with which you may not agree, and if we do not use those proceeds effectively your investment could be harmed.

- You will experience immediate dilution in the book value per share of the Common Stock you purchase in the amount of $3.10 per share of Common Stock.

- Certain recent initial public offerings of companies with relatively small public floats have experienced extreme volatility that was seemingly unrelated to the underlying performance of the company. Our Common Stock may potentially experience rapid and substantial price volatility, and price decline, which may make it difficult for prospective investors to assess what we believe to be the value of our Common Stock.

- Because the underwriter, Public Ventures, LLC is a wholly owned subsidiary of MDB, and MDB prior to the offering beneficially owns 62.88% of our Common Stock, there may be a conflict of interest among the Company, underwriter and MDB in conducting the offering and its terms.

- Concentration of ownership among our existing executive officers, directors and significant stockholders may prevent new investors from influencing significant corporate decisions.

- The price of our Common Stock may have little or no relationship to the historical sales price of our capital stock in our private placement transactions to date.

- Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our Common Stock.

Corporate Information

Our executive offices are located at 750 Royal Oaks Drive, Suite 106, Monrovia, CA 91016. Our phone number is (626) 415-1488. Our website address is www.invizyne.com. The information on our website is deemed not to be incorporated in this prospectus or to be part of this prospectus.

JOBS Act – “Emerging Growth Company”

We have elected to be treated as an emerging growth company, as defined in the JOBS Act. As such, in this prospectus we have elected to take advantage of certain reduced disclosure obligations that apply to emerging growth companies regarding selected financial data and executive compensation arrangements. We expect to continue to rely on the emerging growth company reduced disclosure and reporting obligations once we are a public company.

Implications of Being an “Emerging Growth Company”

An “emerging growth company,” as defined in Section 2(a) of the Securities Act is eligible to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not “emerging growth companies,” such as not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act. We could remain an “emerging growth company” for up to five years, or until the earliest of (a) the last day of the first fiscal year in which our annual gross revenue exceeds $1.235 billion, (b) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act which would occur if the market value of all our shares of Common Stock that are held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter, or (c) the date on which we have issued more than $1 billion in nonconvertible debt during the preceding three-year period.

THE OFFERING

The number of shares outstanding includes the 6,483,351 shares issued as a dividend at the rate of 1.0775673 shares for each issued and outstanding share of Common Stock, declared and paid on February 7, 2024, and excludes:

● 849,301 shares of Common Stock underlying the assigned restricted share units and other awards under the 2020 Equity Incentive Plan as of December 31, 2023;

● 410,586 shares of Common Stock underlying the outstanding warrants and 250,000 shares of Common Stock underlying the SAFE agreements, to be issued immediately after completion of the offering to which this prospectus relates; and

● 2,059,349 shares of Common Stock that may be the subject of future awards under the 2020 Equity Incentive Award Plan as of December 31, 2023; and

● up to 430,000 shares of Common Stock (494,500 shares if the over-allotment is exercised) which may be sold pursuant to the exercise of the warrants issued to the underwriter.

Unless otherwise indicated, all information in this prospectus assumes:

SUMMARY CONSOLIDATED FINANCIAL AND OTHER DATA

The following tables summarize our consolidated financial data and other data. The summary consolidated statements of operations data for the years ended December 31, 2023, and 2022, respectively, and the consolidated balance sheet data as of December 31, 2023, and 2022, have been derived from our consolidated financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected in the future. You should read the following summary consolidated financial data and other data below in conjunction with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus includes statements that express our opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” All statements other than statements of historical facts contained in this prospectus may be forward-looking statements. These forward-looking statements can generally be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “continues,” “anticipates,” “expects,” “seeks,” “projects,” “intends,” “plans,” “may,” “will,” “would” or “should” or, in each case, their negative or other variations or comparable terminology. They appear in a number of places throughout this prospectus, and include statements regarding our intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, growth, strategies, future acquisitions and the industry in which we operate.

These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause our actual results of operations, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results, as well as those of the markets we serve or intend to serve, to differ materially from those expressed in, or suggested by, these forward-looking statements. These forward-looking statements are based on assumptions regarding our present and future business strategies and the environment in which we operate. Important factors that could cause those differences include, but are not limited to:

These above factors should not be construed as exhaustive and should be read with the other cautionary statements in this prospectus.

Although we base these forward-looking statements on assumptions that we believe are reasonable when made, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and industry developments may differ materially from statements made in or suggested by the forward-looking statements contained in this prospectus. The matters summarized under “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and elsewhere in this prospectus could cause our actual results to differ significantly from those contained in our forward-looking statements. In addition, even if our results of operations, financial condition and liquidity, and industry developments are consistent with the forward-looking statements contained in this prospectus, those results or developments may not be indicative of results or developments in subsequent periods.

In light of these risks and uncertainties, we caution you not to place undue reliance on these forward-looking statements. Any forward-looking statement that we make in this prospectus speaks only as of the date of such statement, and we undertake no obligation to update any forward-looking statement or to publicly announce the results of any revision to any of those statements to reflect future events or developments, except as required by applicable law. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless specifically expressed as such, and should only be viewed as historical data.

RISK FACTORS

Investing in our Common Stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information in this prospectus, before making a decision to invest in our Common Stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of or that we deem immaterial may also become important factors that adversely affect our business. If any of the following risks occur, our business, operating results, financial condition and future prospects could be materially and adversely affected. In that event, the market price of the shares of our Common Stock could decline, and you could lose part or all of your investment.

Business Risk Factors

Invizyne has a limited operating history on which to evaluate its ability to achieve its operating objectives.

Invizyne was founded in 2019, and we are a pre-revenue, development stage synthetic biochemical company. We have only a limited operating history and only have incurred losses to date. Therefore, there can be no assurance that the development efforts of Invizyne will produce commercially viable processes or potential products, achieve market acceptance, or generate revenues that will sustain its business. With a limited operating history, no marketing experience, and no commercialized products at this time, it will be difficult for investors to make predictions about the future success or even the viability of Invizyne, and any predictions may not be as accurate as they could be if the Company had a longer operating history or a history of successfully developing, commercializing and generating revenue from products for a mass market.

We cannot assure you that we will generate revenue or become profitable in the future.

As we are a pre-revenue, development-stage technology company, we do not expect to generate revenue or net income until we successfully commercialize our first products over a significant period. As of this date, our technology is still largely in development, and the limited number of products are being produced only at lab scale quantities. We are incurring operating losses, and we cannot assure you that we will generate revenue or be profitable in the future. Our products in development and our future products may never reach commercial scale quantities or become commercially viable. Even if we find commercially viable applications for our technology, which may include licensing, we may never recover our research and development expenses and other start-up expenses.

We will need additional capital after this offering to support our growth. Additional capital, may be difficult to obtain thus restricting our operations and resulting in additional dilution to our stockholders.

Over time, we anticipate that the business will require additional capital to implement the long-term business plan of product development and commercialization. Upon completion of this offering, we believe our cash, cash equivalents and other investments will be sufficient to fund our operations over approximately the next 12 to 24 months.

As we require additional funds, we will explore future financing arrangements for the Company as a whole and financing specific segments of our business by using additional private and public offerings of our securities, borrowings, spinouts, joint ventures, licensing, asset sales and merger transactions. We also will seek government research grants, as they may be available. We cannot be sure that additional financing from any of these sources will be available when needed or that, if available, the additional financing will be obtained on terms favorable to us or our stockholders. If we raise additional funds by selling equity based securities, the ownership interest of our current stockholders will be diluted. If we are unable to obtain additional funds on a timely basis or on terms favorable to us, we may have to cease or reduce certain research and development projects, to sell some or all of our technology or assets or business units or to merge all or a portion of our business with another entity.

The report on our financial statements has been issued with a “going concern” statement.

The financial statements of the Company have been prepared on a going concern basis, which implies that the Company will continue to realize its assets and discharge its liabilities in the normal course of business, but the Company may not have sufficient funds to meet its liabilities and other obligations in the future without additional financial support. The continuation of the Company as a going concern is dependent upon the continued financial support from its shareholders, the ability to raise equity or debt financing, and the attainment of profitable operations from the Company’s future business.

We are unsure if and when we will become profitable.

We have not yet demonstrated our ability to generate revenue, and we may never be able to produce material revenues or operate on a profitable basis. We expect to experience operating losses and negative cash flow for the foreseeable future. We expect to expend significant cash resources on hiring of personnel, continued scientific and potential product research and development, potential product scaling, intellectual property development and prosecution, marketing and promotion, capital expenditures, working capital, and general and administrative expenses. We expect to incur costs and expenses related to consulting costs, laboratory development costs, hiring of scientists, engineers, science and other operational personnel, and the continued development of relationships with strategic and collaborative partners. We are attempting to obtain the currently required working capital for operations through this offering, but we may not be able to obtain financing in a sufficient amount or at all, or on terms that are acceptable to us. We anticipate our losses will continue to increase from current levels during our continuing development stage.

Invizyne may not be successful in its efforts to use its proprietary synthetic biological platform to build a pipeline of products.

A key element of Invizyne’s strategy is to use its experienced management, engineering and scientific teams to build a pipeline of products using its synthetic biological platform and further develop those products into commercially viable products faster and cheaper than possible using traditional materials and methods. Although its research and development efforts, to date, have resulted in what we believe to be potential products, we may not be successful in further developing products to the level of commercial viability or be able to continue to identify and develop these and other products. Even if it is successful in continuing to build a pipeline of products, not all potential products it identifies will be suitable for development and use in commercial products. If Invizyne is unsuccessful in these efforts, the value of the Company will be lost, our investors may suffer a loss in relation to their investment in the Company, and Invizyne may have to curtail or cease its business.

The market, including clients and potential investors, may be skeptical of the viability and benefits of Invizyne’s pipeline products because they are relatively novel and are based on complex technology.

The viability and benefits of our products, which currently include pharmaceutical cannabinoids, and isobutanol (a 2G biofuel), may be difficult to assess because they are based on a relatively novel and complex technology. Invizyne’s technology consists of using multi-stage enzymatic bioconversion systems that we have named SimplePath™. The SimplePath™ platform and the limited number of products that we are developing are currently in various stages of research and development, limited pilot production phase and/or pre-clinical assessment as a therapeutic or product for other uses. It is often an issue that what is possible in the small quantities used at the research level cannot be replicated as production quantities are increased for testing and commercialization. Each product will be required to be progressively scaled up from early research production quantities to show the feasibility of production in larger quantities, whether for clinical evaluation, testing, and ultimately commercial manufacturing amounts before being made available to clients. As Invizyne continues to develop and optimize its SimplePath™ platform and processes to make what it has determined to be the initial potential products in the quantities needed for research, clinical or testing evaluation and manufacturing, there can be no assurance that such products will be understood, approved, or accepted by clients, regulators and potential investors, that the relevant SimplePath™ platform and processes can be used for commercial manufacturing, or that it will be able to sell products at competitive prices and with features sufficient to establish demand and generate revenues or any level of profit. Another consideration is if a product is a candidate as an active pharmaceutical ingredient, then it will require FDA or any other applicable regulatory approvals, including manufacturing approvals, which may not be obtainable. If it is unable to convince potential clients of the utility and value of its products, it will not be successful in entering the markets that it has identified, and its business and results of operations will be adversely affected.

The synthetic biology market is a rapidly expanding and changing market, and if Invizyne is unable to keep up to date with developments, its business may be adversely affected.

Invizyne is operating in a rapidly growing and changing business space within the synthetic biology market. Therefore, the market is becoming more developed and highly competitive. Invizyne will have to continually assess the market and what kinds of products will be in demand. If it fails to anticipate market demands or is not able to meet a market demand in a timely fashion, its research and development efforts will not pay off as expected or at all. The intellectual property aspects of this market are evolving, and patents filed several years ago by potential competitors are currently being granted, which may force Invizyne to license technologies it needs for its processes or to develop a workaround to the valid claims of others. Invizyne may not be able to obtain any necessary licenses or develop processes that do not infringe on others; in which case its business will be impaired and it will be prevented from executing its business plan. The cell-free synthetic biology market in which Invizyne seeks to compete, is relatively new, and therefore the extent to which it may encounter intellectual property of others that limits or restricts its processes is unpredictable.

Invizyne may face unique regulatory hurdles because its bio-synthesized compounds are novel.

Because bio-synthesized compounds are still considered novel, regulators and the public, may perceive them differently from naturally occurring molecules, notwithstanding the fact that molecules are the same whether synthetically created or naturally occurring. Therefore, Invizyne may have to provide additional validation related to the science of its compounds in order to obtain regulatory and market approval to gain product adoption. Providing additional validation will cause delays in development and commercialization, which will result in additional funding requirements than may not have been anticipated. Invizyne may never achieve the required approvals in which case its business model will be impaired. Invizyne may not be able to achieve commercial success.

Because its compounds are novel, Invizyne may have to perform tests for safety, use, and claim validation.

We anticipate, because its compounds are unique, that Invizyne will face all the hurdles of a new technology in a marketplace. Depending on the use of the compounds, Invizyne may have to comply with the extensive array of medical and other areas of regulation depending on the use of the particular compound. In addition, it anticipates having to conduct many forms of tests to convince regulators, commercialization partners and potential users of the safety, uses, and claim validation to be able to commercialize and gain market acceptance for its compounds. If it is unable to successfully justify the efficacy, safety and potential of its compounds, or do so in a timely manner, it will not be able to successfully develop its business and may have to curtail or cease its business. Holders of our shares of Common Stock may lose value in their holdings.

Invizyne is highly dependent on its ability to retain its current scientific and other staff to hire additional employees with specialized backgrounds as needed.

In this early stage of its scientific research and development of its SimplePath™ platform, Invizyne is highly dependent on retaining and motivating its current scientific professionals, other staff and management. We believe that our future success depends on retaining such persons, particularly those with key knowledge about the Invizyne technology, potential products and business objectives within the biochemistry industry. Success also depends on being able to expand its employee base as required. We believe there are relatively few persons with specific knowledge of cell-free synthetic biology. Persons with the talents that Invizyne seeks to hire tend to be in high demand and it may not be able to hire such persons as and when needed. The inability to hire and retain necessary employees may have an adverse impact on its business implementation.

Our ability to retain our senior management and recruit additional senior management is important to the success of our business, and our failure to do so may adversely affect our reputation, business, results of operations and financial condition.

Our ability to hire senior executives and managers with the managerial abilities that we need as we grow and expand will greatly influence our success. Despite our efforts to retain members of our management team, these persons may terminate their employment with us on short notice. The loss of the services of any of our executive officers or other key management and other key employees could potentially harm our business, operating results, or financial condition. Currently, we do not maintain key man insurance policies with respect to any of our executive officers or employees.

Laboratory conditions differ from commercial conditions, which could affect the effectiveness of our potential products. Failures to effectively move from laboratory to commercial scale would harm our business.

Observations and developments that may be achievable under laboratory circumstances may not be able to be replicated in commercial settings. We have observed multiple results that encourage the development of our technology platform. We, however, are not certain that these laboratory results will be able to be replicated at a commercial scale. As we advance our technology, we plan to make products at higher scales until we reach commercially viable scales. If these results obtained at the current levels are not replicated at commercial scales the attractiveness of the technology will be adversely affected and our business may fail to be successful.

Our systems rely on the need for purified enzymes and co-factors for the conversions of input feedstock into final products. We will need to find competitively priced sources of these inputs for our process to be cost competitive and/or develop methods to use these resources efficiently.

We have observed continuous conversion of input feedstock, the raw material from which a product is made, into the final product for a time period of at least seven days. Longer running conversions, we believe, will optimize the use of enzymes and co-factor in the SimplePath™ platform, making it more efficient. Targeted feedstock for our current products are primarily sugars or other readily available chemicals. We believe we can further optimize our technological systems to continue running for longer times than seven days thus optimizing the use of our enzymes and co-factors. Co-factors in our processes are energy molecules such as ATP (adenosine triphosphate, which is a molecule that stores and releases energy in cells) or NADPH (nicotinamide adenine dinucleotide phosphate, which is a molecule that is an essential electron donor and provides the reducing power for anabolic reactions and redox balance). If we fail to find competitively priced sources of these inputs and/or if we fail to show long periods of continued reactions at larger scales our system might not prove to be competitive.

We will be subject to fluctuations in pricing for the products we choose to develop and commercialize.

We prioritize the products we choose to develop by using a number of parameters including the margin between market pricing or expected market pricing versus our expected production cost. Fluctuations in pricing below our cost to manufacture would make the commercialization of such product unfeasible. The result would be that we would not be able to sustain our business from revenue, and as a result we may have to curtail or cease operations.

We believe that in the future we will require additional capital to support operations and business growth; this capital might not be available when needed.

We have funded our operations to date through private placement equity financings, in large part from MDB Capital Holdings, LLC, our majority shareholder, and currently our parent company. We cannot rely on additional funds from our current shareholders or our parent. We cannot be certain when or if our operations will generate sufficient cash to fund our ongoing operations or the growth of our business. We intend to continue to make investments in our business to respond to business opportunities and challenges, including refining our technologies, developing new products, enhancing our operating infrastructure, and expanding our operations. All of the foregoing will require us to secure additional funds to those obtained in this offering. Additional financing may not be available on terms favorable to us, if at all. If we incur additional debt, or issue preferred equity securities, the holders of these debts or preferred security holders would have rights senior to holders of our equity to make claims on our assets, and the terms of any debt could restrict our operations, including our ability to make distributions on our equity. Because our decision to raise capital in the future will depend on numerous considerations, including factors beyond our control, we cannot predict or estimate the amount, timing, dilutive effect or nature of any future issuances of securities. As a result, our equity holders bear the risk that future issuances of debt or equity securities could reduce the value of our Common Stock and dilute their interests. Our inability to obtain adequate financing or financing on terms satisfactory to us, when we require it, could significantly limit our ability to continue supporting our business growth and responding to business opportunities and challenges.

Our business depends upon our ability to make good decisions regarding the deployment of capital and, ultimately, the performance of our products which is uncertain.

If our management and scientific staff make poor decisions regarding the deployment of capital into new or existing research, products and strategic partners for commercialization, our business model may not succeed. Our success ultimately depends on our ability to choose the right products, services and companies to further commercialize our science. If one or more of these aspects of our business and decisions do not succeed by themselves or together, the value of our assets could be significantly reduced resulting in substantial impairments or write-offs, which could cause the results of our operations and the price of our Common Stock to decline.

Our success depends, in part, on the successful development of our science technologies and our products.

To be successful, we will need to continue to develop our science technologies and the products that we can offer to commercialization entities. If we do not anticipate correctly and respond with products that are commercially acceptable, we will not be successful. In that event, the value of our business and overall company value would be diminished.

We are subject to risks relating to portfolio concentration.

Currently, our business is highly dependent on a small number of products, which are based on our principal technology. If these products cannot be fully commercialized or are not accepted in the market, we will have expended significant financial, development and corporate assets that will not necessarily be recovered. Therefore, investors may lose a portion or all of their investment in Invizyne.

We do not have any sales, marketing, manufacturing and distribution capabilities or arrangements, and will need to create these as we move towards commercialization of our products.

We do not yet have a full sales, marketing, manufacturing or distribution capacity. To date sales and marketing have been conducted by senior management staff, and been a part of their other management obligations. To be able to commercialize our potential products, we will need to develop all of the foregoing elements of commercialization. We do not have any corporate experience in establishing these capabilities, and therefore, we may be unsuccessful in achieving commercialization and earning revenues. We believe that setting up the commercialization aspects of a company will take a substantial amount of capital and commitment of time and effort. We plan on seeking development and marketing partners and license our technology to others or develop contract manufacturing partners in order to avoid our having to provide the full range of marketing, manufacturing and distribution capabilities within our organization. There can be no assurance that we will find any development and marketing partners or companies that are interested in licensing our technology. If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, independently or with others, we will not be able to generate product revenue, and may not become profitable.

Collaborations of various sorts, by our partner companies, such as with respect to research, testing, manufacturing and distribution, will be important to our business. The inability to enter into collaboration arrangements as needed, or if such collaborations are not successful, may adversely impact our business.

We will likely seek to collaborate with third parties to engage in aspects of product research, testing, marketing, manufacturing, and distribution as part of our commercialization strategy. If we are not able to enter into these kinds of agreements or maintain collaboration arrangements, as needed and on reasonable terms, our ability to develop our business could be delayed, or the costs of development and commercialization increased beyond what would be reasonable and ultimately hindered to the point of business cessation. Furthermore, we may need to obtain the use of intellectual property rights held by third parties in order to develop our products. As a result, the growth of a particular business endeavor or product may depend in part on the ability to acquire or in-license these intellectual property rights.

Future collaboration arrangements may pose a number of risks, including, but not limited to, the following:

(i) collaborators have significant discretion in determining the efforts and resources that they will apply;

(ii) collaborators may not perform their obligations as expected;

(iii) collaborators may elect not to continue or renew development or commercialization programs or license arrangements;

(iv) collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our technologies and products or products the collaborators have may be viewed as competitive with our technologies and products causing them to cease to devote resources to the commercialization of our products;

(v) collaborators may fail to comply with applicable regulatory requirements regarding the development, manufacture, distribution or marketing of a product candidate or product or service;

(vi) collaborators may not commit sufficient resources to the marketing and distribution of our products;

(vii) disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or terminations of the research, development or commercialization of products, might lead to additional responsibilities for us, or might result in litigation or arbitration, any of which would be time- consuming and expensive;

(viii) collaborations may be terminated by the collaborator, and, if terminated, we may require more capital to pursue further development or commercialization of the applicable product or service; and

(ix) collaborations may not be negotiated on a timely basis or acceptable terms, if at all, or they may require substantial additional capital so as to be able to pursue and fund a collaboration.

If collaborations do not result in the successful discovery, development and commercialization of product candidates or if one of the collaborators terminates its agreement, our partner companies may not receive any future research funding or milestone or royalty payments under such collaboration. If a collaborator terminates its agreement, the partner company may find it more difficult to attract new collaborators, and the perception of the product or the business and financial condition of our partner company could be adversely affected.

We expect to experience competition from other companies and research institutions.

Considerable efforts have been, and are being, devoted to engineering living organisms to produce useful chemicals ranging from high-value natural products like cannabinoids to low-value products such as, fuels, plastics, and building block chemicals. Given the broad and growing attention to the environment and the environmental benefits of synthetic biochemistry, many players are attracted to the industry. Currently, there are many companies in the synthetic biology market, including, well known firms operating on the industry segments of life science and biology solutions, pharmaceuticals, meat, beauty, agriculture, automobile, and fashion. The number of companies and scope of industry segments touched upon demonstrate this is an active, developing industry.

We believe that we will face competition from many companies and research institutions that are currently working in, and will enter, the industry to work on all the many aspects of cell-free synthetic biochemistry. Debut Biotech and Solugen Inc. promote the advantages of cell-free enzymatic systems over cell-based systems, but their processes appear to use simple one to two step pathways. Codexis, Inc. partnered with Tate&Lyle and Merck & Co., Inc. on different, highly specific projects that use multi enzyme pathways, which demonstrate that enzymatic Islatravir synthesis illustrates the potential for complex or longer enzyme cascades of the type used in some of our SimplePath™ systems, but their principal mission diverges from the enzymatic manufacturing of more general chemicals. There are many companies that focus on enzyme engineering, such as Codexis, Inc., Allozymes Pte Ltd. (Singapore), Enzymit Ltd. (Israel and US), Zymtronix Catalytic Systems, Inc., Arzeda Corp. and Quantumzyme LLP (India). There are other companies that develop enzyme immobilization technologies. There are many companies operating in the biofuels space, such as Valero Energy Corporation, ADM Corporation and Cargill Company and Gevo, Inc. and Butamax Advanced Biofuels LLC that focus on ethanol technologies.

We believe that a majority of the companies that present some aspect of competition are well established companies that have more experience identifying and carrying out the scientific development required in the research and development of products that will be competitive to those of Invizyne. Many of these companies have, and others that we anticipate entering the market in the future will have, greater financial and management resources, brand or science name recognition or industry contacts than we possess. A number of the companies are multinational companies and many are also publicly listed companies, with large market capitalizations.

We believe that we compete with those firms based on a number of factors, including our founders’ reputation and history, our work and successes to date since founding, our willingness and ability to strategically partner with other companies, the overall abilities and experience of our management and staff, and our ability to use our technologies to develop new products and create products for potential commercialization opportunities. We also believe we compete based on our unique technological approach. We believe our scientific approach and technology is not as specialized as those of our competitors, thereby opening product pathways for a plethora of more diverse chemical manufacturing applications. We believe that our intellectual property on recycling of essential cofactors will allow us to efficiently operate extensive multistep processes outside of a living cell. This represents a competitive advantage over traditional synthetic biochemical companies. In the biofuels sector, because isobutanol is our primary target due to it being widely regarded as a superior biofuel, we do not compete directly with ethanol producers.

The COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business and operations.

The COVID-19 pandemic has prompted national, regional, and local governments, including those in the markets that the Company operates in, to implement preventative or protective measures to control its spread. As a result, there have been disruptions in business operations around the world. While the Company will continue to navigate the financial, operational, and personnel challenges presented by the COVID-19 pandemic, the full impact of COVID-19 on our operational and financial performance will depend on future developments, including the duration and any further intensification and spread of the pandemic, the potential uncertainty related to (and proliferation of) new strains, and related actions taken by federal, state, local and international government officials, to prevent and manage the spread of COVID-19. All of these efforts are uncertain, out of our control, and cannot be predicted at this time.

Impact of International Conflicts

Currently, we believe that the conflict between Ukraine and Russia and the Israeli conflict situation do not have any direct impact on our operations, financial condition or financial reporting. We believe the conflicts will have only a general impact on our operations in the same manner as it is having a general impact on all businesses that have their operations in North America as a result of international sanctions and embargo regulations, possible shortages of goods and goods incorporating parts that may be supplied from the Ukraine, Russia, Israel and their respective trading partners, supply chain challenges, and the international and US domestic inflationary results of the conflicts and government spending for and funding of our country’s responses. We do not believe we will be targeted for cyber-attacks in connection with the conflicts, but we may be a general target for cyber-attacks being a US based company. We have no operations in the countries directly involved in the conflicts or are specifically impacted by any of the sanctions and embargoes, as we operate in the United States. We do not believe that the conflicts will have any impact on our internal control over financial reporting. Other than general securities market trends, we do not have reason to believe that investors will evaluate the company as having special risks or exposures related to the conflicts. We have no operations in the countries directly involved in the conflict or are specifically impacted by any of the sanctions and embargoes, as we principally operate in the United States. Other than general securities market trends, we do not have reason to believe that investors will evaluate the company as having special risks or exposures related to the Ukrainian conflict.

Risks Related to Intellectual Property and Other Legal Matters

If we are unable to protect the intellectual property used in our technology platform and products, others may be able to copy our innovations which may impair our ability to compete effectively in our markets.

As of January 1, 2024, we have a number of licensed patents, issued patents and patent applications with the USPTO. In addition to the patents and patent applications, we have several other invention disclosures and proprietary trade secrets. The licensed patents are for a suite of patents issued to the University of California Los Angeles (UCLA), which safeguard different aspects of recycling co-factors (i.e. energy molecules), cannabinoid biosynthesis, and stable enzymes, which are enzymes that have been engineered for thermostability or other attributes that allow the enzyme to last longer and/or perform more efficiently. This current consolidated portfolio provides a defendable position that enables the creation of complex, robust, sustainable enzyme systems.

We also are pursuing patent applications in jurisdictions other than the United States where we believe such protection is warranted in relation to the development and marketing of our processes and products.

As our research develops, we believe the Invizyne inventions and license will be able to cover a wide range of technologies that relate to biomanufacturing. These inventions include new chemical entities, composition of matter intellectual property on novel and engineered individual enzymes with changes in stability, activity, specificity, or a combination thereof, as well as systems of enzymes designed for pioneering novel manufacturing processes. Additionally, our intellectual property includes cofactor and metabolite management optimized for sustained reaction continuity and advancements in enzyme expression strains and processes. Medabilites result from the break up of a molecule, from which we can select those parts that are able to modify the speed of or stop an enzyme reaction, and which we use to manage the reaction timing of our SimplePath™ platform. Enzyme expression is the process of selection for of those cells that will make enzymes with particular qualities that optimize our SimplePath™ platform.

Our patent applications may be challenged or fail to result in issued patents and our existing or future patents may be too narrow to prevent third-parties from developing or designing around our intellectual property and in that event we may lose competitive advantage and our business may suffer. Further, the patent applications that we license may fail to result in issued patents. The claims may need to be amended. Even after amendment, a patent may not issue and in that event, we may not obtain the exclusive use of the intellectual property that we seek and may lose competitive advantage which could result in harm to our business.

If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.

In addition to patents and patent applications in respect of our technology, we rely upon, among other things, unpatented proprietary technology, processes, trade secrets and know-how. Any involuntary disclosure to or misappropriation by third-parties of our confidential or proprietary information could enable competitors to duplicate or surpass our technological achievements, potentially eroding our competitive position in our market. We seek to protect confidential or proprietary information in part by confidentiality agreements with our employees, consultants and third-parties. While we require all of our employees, consultants, advisors and any third-parties who have access to our proprietary know-how, information and technology to enter into confidentiality agreements, we cannot be certain that this know-how, information and technology will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. These agreements may be terminated or breached, and we may not have adequate remedies for any such termination or breach. Furthermore, these agreements may not provide meaningful protection for our trade secrets and know-how in the event of unauthorized use or disclosure. To the extent that any of our staff were previously employed by other synthetic biology companies, those employers may allege violations of trade secrets and other similar claims in relation to their product development activities for us.

If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third-parties, we could lose license rights that are important to our business.

We hold exclusive licenses from The Regents of the University of California, (“The Regents”) to intellectual property relating to cell-free synthetic biochemistry technology. These licenses impose various developmental milestone obligations on us. If we fail to comply with any material obligations, the licensor will have the right to terminate the applicable license. The existing or future patents to which we have rights based on our agreements with The Regents may be too narrow to prevent third-parties from developing or designing around these patents. Additionally, we may lose our rights to the patents and patent applications we license in the event of a breach or termination of the license agreement. Should the license terminate we retain the right to utilize the intellectual property, but may not be able to prevent others from doing so, in which case we may lose a competitive advantage.

Our license fees to The Regents may exceed our income from product revenues based on the licensed patents.

The license we hold from The Regents provides for annual license fees and royalties based on income derived from the licensed patents. It is possible that our fees to The Regents may exceed our income. In such an event, we would have to fund the fees from other sources, such as working capital, financings or other income. If we do not make the payments, as and when required, we would be in breach of the license agreement and The Regents would be able to terminate the license.

If we or our licensors are unable to protect our/their intellectual property, then our financial condition, results of operations and the value of our technology and products could be adversely affected.

We believe patents and other proprietary rights are essential to our business. Our success will depend in part on the ability of our licensors to obtain, to maintain (including making periodic filings and payments) and to enforce patent protection for their intellectual property, in particular, those patents to which we have secured exclusive rights. We, and our licensors, may not successfully prosecute or continue to prosecute the patent applications which we have licensed. Even if patents are issued in respect of these patent applications, we or our licensors may fail to maintain these patents, may determine not to pursue litigation against entities that are infringing upon these patents, or may pursue such enforcement less aggressively than we ordinarily would. Without adequate protection for the intellectual property that we own or license, other companies might be able to use substantially identical methods of production, which could unfavorably affect our competitive business position and harm our business prospects. Even if issued, patents may be challenged, invalidated, or circumvented, which could limit our ability to stop competitors from using similar methods of production or limit the length of term of patent protection that we may have for our methods of manufacturing our products.

Litigation or third-party claims of intellectual property infringement or challenges to the validity of our patents would require us to use resources to protect our technology and may prevent or delay our development or commercialization of our product candidates.

If we are the target of claims by third parties asserting that our methods of production, enzymatic pathways or intellectual property infringe upon the rights of others, we may be forced to incur substantial expenses or divert substantial employee resources from our business. If successful, those claims could result in our having to pay substantial damages or could prevent us from developing one or more products. Further, if a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.

If we or our collaborators experience patent infringement claims, or if we elect to avoid potential claims others may be able to assert, we or our collaborators may choose to seek, or be required to seek, a license from the third-party and would most likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which would give our competitors access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms. This could harm our business significantly. The cost to us of any litigation or other proceeding, regardless of its merit, even if resolved in our favor, could be substantial. Some of our competitors may be able to bear the costs of such litigation or proceedings more effectively than we can because of their having greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Intellectual property litigation and other proceedings may, regardless of their merit, also absorb significant management time and employee resources.

Third-party claims of intellectual property infringement may prevent or delay our development and commercialization activities for other products.

Although we are not currently aware of any litigation or other proceedings or third-party claims of intellectual property infringement, the synthetic biology industry is characterized by many litigation cases regarding patents and other intellectual property rights. Other parties may in the future allege that our activities infringe their patents or that we are employing their proprietary technology without authorization. We may not have identified all the patents, patent applications or published literature that affect our business either by blocking our ability to commercialize our product, by preventing the patentability of one or more aspects of our products or those of our licensors or by covering the same or similar technologies that may affect our ability to market our product. In addition, even in the absence of litigation, we may need to obtain licenses from third-parties to advance our research or allow commercialization of our product. We may fail to obtain future licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be unable to further develop and commercialize one or more of our products, which could harm our business significantly.

We may become involved in future lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may file infringement claims, which can be expensive and time consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or of our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

The US Patent and Trademark Office may initiate interference proceedings to determine the priority of inventions described in or otherwise affecting our patents and patent applications or those of our collaborators or licensors. An unfavorable outcome could require us to cease using the technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if a prevailing party does not offer us a license on terms that are acceptable to us. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distraction of our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our proprietary rights, particularly in countries where the laws may not protect those rights as fully as in the US.

If trademarks and trade names are not adequately protected, then we may not be able to build name recognition in the markets of interest and our business may be adversely affected.

A trademark or trade name may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to our trademarks and trade names or may be forced to stop using our names. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trade names or trademarks that incorporate variations of our unregistered trade names or trademarks. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.

Risks Related to this Being a Public Company

We will incur increased costs as a result of operating as a public company, and our board of directors will be required to devote substantial time to oversight of new compliance requirements and corporate governance practices.

As a public company listed in the U.S., we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq, and other applicable securities rules and regulations impose various requirements on listed public companies, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our board of directors, management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified members of our board of directors.

However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, we will be required to furnish a report by our board of directors on our internal control over financial reporting. However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal controls over financial reporting, which is both costly and challenging. In this regard, we will need to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe, that our internal controls over financial reporting are effective as required by Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company” which would allow us to take advantage of many of the same exemptions from disclosure requirements including not being required to comply with the auditor attestation requirements of Section 404 and reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements. We cannot predict if investors will find our shares of Common Stock less attractive because we may rely on these exemptions. If some investors find our shares of Common Stock less attractive as a result, there may be a less active trading market for our shares of Common Stock, and our share price may be lower or more volatile.

We are a smaller reporting company within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to smaller reporting companies, this could make our securities less attractive to investors and may make it more difficult to compare our performance with other public companies.

Rule 12b-2 of the Exchange Act defines a “smaller reporting company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that:

As a smaller reporting company, we are not required to include a Compensation Discussion and Analysis section in our proxy statements; we will provide only two years of financial statements; and we need not provide the table of selected financial data. We also will have other “scaled” disclosure requirements that are less comprehensive than issuers that are not smaller reporting companies which could make our securities less attractive to potential investors, which could make it more difficult for our security holders to sell their securities.

We currently have limited accounting personnel with the background in public company accounting and reporting. We will have to add personnel and devote personnel and financial resources to meet our reporting obligations as a publicly listed company.

We have been a private company with limited operating scale. As of the date of this prospectus, we do not have the appropriate accounting personnel to adequately execute our accounting processes and other supervisory resources with which to address our internal control over financial reporting. We are in the process of hiring additional personnel and putting in place protocols necessary to implement appropriate accounting policies, processes and controls to address the anticipated change in the scale of our operations. However, we cannot assure you that the measures we have taken to date, and actions we plan to take in the future, will be sufficient to prevent or avoid potential future material weaknesses in our controls.

If we fail to develop or maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent financial fraud. As a result, current and potential stockholders could lose confidence in our financial reporting.

Invizyne is subject to the risk that it has deficiencies in its internal control structure. A deficiency in internal control over financial reporting is one that indicates there is more than a remote likelihood that a material misstatement of the entity’s financial statements will not be prevented or detected by the entity’s internal controls. Effective internal control is necessary to provide reliable financial reports and effectively prevent fraud. If we cannot provide reliable financial reports or prevent fraud, we could be subject to regulatory action or other litigation and our operating results could be harmed. Our lack of sufficient, appropriate accounting personnel is one such deficiency.

It may be time consuming, difficult, and costly for the Company to develop and implement the internal control and reporting procedures required by the Exchange Act. The Company, at this time, will need to hire additional financial reporting, internal control, and other finance personnel in order to develop and implement appropriate internal control and reporting procedures. If we are unable to comply with the internal control over financial reporting requirements of the Exchange Act, then we may not be able to obtain the required independent accountant certifications, which may preclude us from keeping our filings current with the SEC. Further, a material weakness in the effectiveness of internal control over financial reporting could result in an increased chance of fraud, reduce our ability to obtain financing, and require additional expenditures to comply with these requirements, each of which could have a material adverse effect on our business, results of operations, and financial condition.

Certain recent initial public offerings of companies with relatively small public floats have experienced extreme volatility that was seemingly unrelated to the underlying performance of the company. Our Common Stock may potentially experience rapid and substantial price volatility, and price decline, which may make it difficult for prospective investors to assess what we believe to be the value of our Common Stock.

In addition to the general volatility risks discussed in this Prospectus, our Common Stock may be subject to rapid and substantial price volatility and/or a decline in the market price. We may experience extreme stock price volatility unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our Common Stock. Recently, there have been instances of extreme stock price run-ups followed by rapid price declines and strong stock price volatility with a number of recent initial public offerings, especially among companies with relatively small public floats. As we anticipate having a relatively small public float, the Common Stock may experience greater stock price volatility, extreme price run-ups, rapid declines in the price, lower trading volume, large spreads in bid and asked prices, and less liquidity than large-capitalization companies. The aspects of the trading in the Common Stock may be unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the value of our Common Stock. Because of the low public float and the absence of any significant trading volume, the reported prices may not reflect the price at which an investor would be able to sell shares if it wants to sell any shares or buy shares if it wishes to buy share.

If the trading volumes of our Common Stock is low, persons buying or selling in relatively small quantities may easily influence the prices of the Common Stock. A low volume of trades could also cause the price of the Common Stock to fluctuate greatly, with large percentage changes in price occurring in any trading day session. Broad market fluctuations and general economic and political conditions may also adversely affect the market price of the Common Stock. The volatility also could adversely affect the ability of the Company to issue additional shares of Common Stock or any other securities and the ability to obtain stock market based financing in the future. No assurance can be given that an active market in our Common Stock will develop or be sustained.

The absence of security analytical reports or the existence of negative security analytical reports may have an adverse effect on the public market price and volume of our shares of Common Stock.

Any trading market for our shares of Common Stock may be influenced by whether or not any analytical research reports are published about us. We do not currently have and may never obtain research coverage by securities industry analysts. If no securities industry analysts commence coverage of us, the market price and market trading volume of our shares of Common Stock could be negatively affected. In the event we are covered by analysts, and one or more of such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage of us, the market price and market trading volume of our shares of Common Stock could be negatively affected.

Risks Related to the Offering

Concentration of ownership among our existing executive officers, directors and significant stockholders may prevent new investors from influencing significant corporate decisions.

All decisions with respect to the management of the Company will be made by our board of directors and our officers, who, before this offering, beneficially own approximately 93.57% of our issued and outstanding Common Stock. Included in that percentage is the beneficial share ownership by MDB Capital Holdings, LLC because two of its officers are also directors of the Company. MDB Capital Holdings, LLC, is our parent company and the controlling shareholder before this offering, beneficially owning 62.97% of our shares of Common Stock. After this offering MDB Capital Holdings, LLC will beneficially own 47.38% of our common stock. Mr. Hayat, our Chairman of the Board is also an officer of MDB Capital Holdings, LLC, but he has no voting authority over the securities owned by MDB Capital Holdings, LLC. After the issuance of our Common Stock in this offering, management will beneficially own approximately 71.22% of our issued and outstanding shares of Common Stock. It is expected that these persons will continue to have aligned interests as they have had prior to this offering, and, therefore, these stockholders will be able to exercise a significant level of control over all matters requiring stockholder approval, including the election of directors, amendment of our articles of incorporation and approval of significant corporate transactions. This control could have the effect of delaying or preventing a change of control of the company or changes in management, in each case, which other stockholders might find favorable, and will make the approval of certain transactions difficult or impossible without the support of these significant stockholders.

The underwriter of this offering, Public Ventures, LLC, is a wholly owned subsidiary of MDB, our current majority shareholder and parent company. This ownership may present a conflict of interest in respect of the offering.

Because the underwriter of this offering, Public Ventures, LLC and Invizyne are both subsidiaries of the same holding company parent, MDB Capital Holdings, LLC, and Messrs. Christopher Marlett, Anthony DiGiandomenico are majority shareholders of our parent, MDB Capital Holdings as well as directors of MDB and directors of the Company, and Mo Hayat, Chairman of the Board and President of the Company, is also Chief of Entrepreneurship & Operations of MDB, a “conflict of interest” within the meaning of FINRA Rule 5121 is deemed to exist under FINRA Rule 5121. This rule requires, among other things, that a “qualified independent underwriter” participate in the preparation of, and exercise the usual standards of “due diligence” with respect to, the registration statement and this prospectus. Digital Offering LLC. has agreed to act as qualified independent underwriter for this offering and to undertake the legal responsibilities and liabilities of an underwriter under the Securities Act. Digital Offering LLC will receive $100,000 but will not receive any additional fees for serving as qualified independent underwriter in connection with this offering. Although Digital Offering LLC has, in its capacity as qualified independent underwriter, participated in due diligence and the preparation of this participation prospectus and the registration statement of which this prospectus forms a part, this may not adequately address all potential conflicts of interest. We have agreed to indemnify Digital Offering LLC against liabilities incurred in connection with acting as qualified independent underwriter, including liabilities under the Securities Act. Pursuant to FINRA Rule 5121, no underwriter having a conflict of interest under FINRA Rule 5121 will confirm sales of our common stock to any account over which it exercises discretionary authority without the specific prior written approval of the of the accountholder. See Prospectus Summary and “Underwriting (Conflicts of Interest)” for additional information.”

The price of our Common Stock may have little or no relationship to the historical sales price of our capital stock in our private placement transactions to date.

Prior to the registration and listing of our Common Stock on the Nasdaq there has been no public market for our capital stock. We have conducted only two private placements, both of which were with our parent corporation; there for we do not have any history of sales by which to judge the value of our Common Stock in a public market or to gage demand for the shares of Common Stock in a public market.

The per share price of $4.00 was determined by our board of directors and the underwriter. The board of directors did not consult any other persons or entities to determine the exercise price, including any valuation experts or appraisers to review any of our assets, our business plan or prospects. They, however, did take into account the current assets, including cash and cash equivalents, of the Company, the research and development achieved by the development team, the patent and patent application portfolio and other intellectual property, and expectations about the potential products and market potential thereof. The per share price is not necessarily related to our book value, net worth or any other established criteria of value and may or may not be considered the fair value of our Common Stock. We cannot assure you that the market price of our Common Stock will not decline during or after this offering. We also cannot assure you that you will be able to sell shares of our Common Stock purchased in this offering at the public offering price or greater in the future.

Prior to the completion of this offering, there has been no public trading market for our Common Stock. An active public trading market for our Common Stock may not develop and our Common Stock may trade below the public offering price.

Prior to the closing of our initial public offering, there has been no public market for our Common Stock. While we have applied to list our Common Stock on the Nasdaq Capital Market (“Nasdaq”), we cannot assure you that our application will be approved or, if approved, that an active public market for our Common Stock will develop. Additionally, approval of our shares of Common Stock to be listed on Nasdaq is a closing condition of the initial public offering under our agreement with the underwriter.

If an active trading market for our Common Stock does not develop after the initial public offering, the market price and liquidity of our Common Stock may be materially and adversely affected. Investors in our Common Stock may experience a significant decrease in the value of their Common Stock regardless of our operating performance or prospects. If we are unable to develop a market for our Common Stock after this offering, investors in our Common Stock may not be able to sell their shares at prices an investor considers to be fair or at times that are convenient for the investor, or at all.

The sale or potential sale by the selling security holder of its 8,027,538 shares of Common Stock may cause the market price of our Common Stock to decline.

At the same time as we are registering shares of Common Stock to be sold in this offering, we are registering for MDB Capital Holdings, LLC, our parent company and largest single shareholder, as a selling security holder, 8,027,538 of the total of 8,272,851 shares of Common Stock that it beneficially holds. The 8,272,851 beneficially owned shares represent 62.88% of the total issued and outstanding shares of Common Stock before the offering and will represent 47.38% of the total issued and outstanding shares of Common Stock after the offering, in each case assuming no exercise of any outstanding equity awards, warrants owned by other security holders or the underwriter overallotment option. The investors in this offering together will hold 4,300,000 shares of Common Stock, representing 23.88% of the outstanding shares of Common Stock after the closing of the offering, assuming conversion of the SAFE’s and no exercise of any outstanding equity awards, warrants of other security holders, or the underwriter overallotment option.

The sale of our Common Stock by the selling security holders could increase the share selling volume and could adversely impact the price of the Common Stock in the securities market to be at a price less than the price at which shares are being offered hereby. Investors in this offering may not be able to sell their shares of Common Stock to recover their purchase price and may have to hold their shares of Common Stock for a long period of time.

The conversion of outstanding SAFE securities will dilute the ownership of investors in this offering.

On July 3, 2023, the Company issued two SAFE securities for proceeds of $800,000, which will convert into approximately 250,000 shares of Common Stock upon the closing of the offering based on a per share price of $3.20 under the terms of the SAFE. On a post-offering basis, assuming no exercise of any outstanding equity awards, warrants or the underwriter overallotment option, these shares will represent 1.46% of the issued and outstanding shares of Common Stock of the Company. As a result, there will be a dilution of the investors’ aggregate interest in the Company by the issuance of the shares of Common Stock.

Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our Common Stock.

If, after listing, we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements, the minimum capital requirements, or the minimum closing bid price requirement, Nasdaq may take steps to delist our Common Stock. Such a delisting would likely have a negative effect on the price of our Common Stock and would impair your ability to sell or purchase our Common Stock when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

We are an “emerging growth company” under the JOBS Act and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our Common Stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our Common Stock less attractive because we may rely on these exemptions. If some investors find our Common Stock less attractive as a result, there may be a less active trading market for our Common Stock and our stock price may be more volatile.

We will remain an “emerging growth company” for up to five years, although we will lose that status sooner if our revenues exceed $1 billion, if we issue more than $1 billion in non-convertible debt in a three year period, or if the market value of our Common Stock that is held by non-affiliates exceeds $700 million as of any June 30.

Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it.

Because of the exemptions from various reporting requirements provided to us as an “emerging growth company,” we may be less attractive to investors and it may be difficult for us to raise additional capital as and when we need it. Investors may be unable to compare our business with other companies in our industry if they believe that our reporting is not as transparent as other companies in our industry. If we are unable to raise additional capital as and when we need it, our financial condition and results of operations may be materially and adversely affected.

Even if a public market for our Common Stock develops, it may be volatile. This may affect the ability of our investors to sell their shares as well as the price at which they may be able to sell their shares.

Even if a market for our Common Stock develops, the market price for the shares may be significantly affected by factors such as variations in quarterly and yearly financial operating results, general trends in the biochemistry industry, our operations and our ability to produce and commercialize products. Furthermore, in recent years the stock market has experienced extreme price and volume fluctuations that are unrelated or disproportionate to the operating performance of the affected companies. Such broad market fluctuations may adversely affect the market price of our Common Stock and adversely affect the ability of investors in the Company to buy and sell the Common Stock.

Assuming a market for our Common Stock develops, shares eligible for future sale may adversely affect the market for our Common Stock.

Commencing on the 90th day following the close of this offering, certain of our current stockholders holding a significant amount of our outstanding shares of Common Stock may be eligible to sell all or some of their shares of Common Stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144, promulgated under the Securities Act, subject to certain limitations and lock-up agreements. In general, pursuant to Rule 144, non-affiliate stockholders may sell freely after six months subject only to the current public information requirement (which disappears after one year). Any substantial sale of our Common Stock pursuant to Rule 144 or pursuant to any resale prospectus (including sales by investors of securities acquired in connection with this offering) may have a material adverse effect on the market price of our Common Stock.

Following the completion of the offering, we may be at an increased risk of securities class action litigation.

Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because the public securities market for small cap companies have experienced significant share volume and price volatility in recent years. If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

We have not paid cash dividends in the past and have no immediate plans to pay cash dividends.

We plan to reinvest all of our earnings, to the extent we have earnings, in order to further develop our technology and potential products and to cover operating costs. We do not plan to pay any cash dividends with respect to our securities in the foreseeable future. We cannot assure you that we would, at any time, generate sufficient surplus cash that would be available for distribution to the holders of our Common Stock as a dividend. Therefore, you should not expect to receive cash dividends on the Common Stock we are offering.

We may allocate the net proceeds from this offering in ways that differ from the estimates discussed in the section titled “Use of Proceeds” and with which you may not agree, and if we do not use those proceeds effectively your investment could be harmed.

The allocation of net proceeds of this offering set forth in the section of this prospectus captioned “Use of Proceeds” represents our estimates based upon our current plans and assumptions regarding industry and general economic conditions, and our future revenues and expenditures. The amounts and timing of our actual expenditures will depend on numerous factors, including market conditions, cash generated by our operations, business developments and related rate of growth. We may find it necessary or advisable to use portions of the proceeds from this offering for other purposes. Circumstances may give rise to a change in the use of proceeds. You may not have an opportunity to evaluate the economic, financial or other information on which we base our decisions on how to use our proceeds. As a result, you and other stockholders may not agree with our decisions. If we do not use the net proceeds that we receive in this offering effectively, our business, results of operations and financial condition could be harmed.

You will experience immediate dilution in the book value per share of the Common Stock you purchase.

Because the price per share of our Common Stock being offered is substantially higher than the book value per share of our Common Stock, you will experience substantial dilution in the net tangible book value of the Common Stock you purchase in this offering. Based on the offering price of $4.00 per share, you will experience immediate and substantial dilution of  $3.10 per share in the net tangible book value of the Common Stock at December 31, 2023, based on the sale of 4,300,000 shares of Common Stock.

USE OF PROCEEDS

We estimate that the net proceeds to us from the sale of our Common Stock in this offering will be approximately $15,473,747 million, and if the overallotment option is exercised $19,258,000, based on the public offering price of $4.00 per share, after deducting commissions and the estimated offering expenses estimated to be about $522,253. The table below indicates the expected uses and amounts for those uses based on the offering amount. Any additional amounts received from the exercise of the over-allotment option will be added to working capital and other general purposes.

The expected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve and change. As a result, our management will have broad discretion over how these proceeds are used. Proceeds held by us will be invested in short-term investments, such as bank deposits and United States government securities, until needed for the uses described above.

DIVIDEND POLICY

Since our inception we have not paid any cash dividends or cash distributions related to our equity securities. We do not plan on declaring or paying cash dividends or cash distributions while we are developing our business. Whether any dividends or distributions are made in the future, if at all and whether or not they are payable in cash, will depend on many factors and will be determined by the board of directors, from time to time, and will depend on, among other things, our results of operations, financial condition, cash requirements, contractual restrictions and other factors that the board of directors may deem relevant. In addition, our ability to pay dividends or make distributions in any form may be limited by covenants of any outstanding superior ranking equity, such as preferred stock, or indebtedness that we incur. Investors should not look to any cash dividend or cash distribution that we might make to be a regular income item in an investor’s portfolio.

The Company made a stock dividend distribution on February 7, 2024, at the rate of 1.0775673 for each issued and outstanding share of Common Stock. The board of directors of the Company has no current plans to declare any additional stock dividends or declare any stock splits at this time.

CAPITALIZATION

The following table sets forth our cash and capitalization as of December 31, 2023 (audited) on:

The table above excludes the following shares:

DILUTION

If you invest in our Common Stock in this offering, your interest will be diluted to the extent of the difference between the public offering price per share of Common Stock and the pro forma as adjusted net tangible book value per share of our Common Stock immediately after the closing of this offering. Net tangible book value per share of Common Stock represents our total tangible assets less our total liabilities, divided by the number of outstanding shares of Common Stock. Our net tangible book value of our Common Stock as of December 31, 2023 was $(384,319), or $(0.03) per share of Common Stock.

After giving effect to the receipt of the net proceeds from our sale of 4,300,000 shares of Common Stock in the offering at the public offering price of $4.00 per share of Common Stock, after deducting commissions and the estimated offering expenses payable by us of $522,253, our pro forma as adjusted net tangible book value as of December 31, 2023, would have been approximately $15.1 million, or $0.90 per share of Common Stock. This represents an immediate increase in pro forma net tangible book value of $0.93 per share to our existing shareholders and an immediate dilution of $3.10 per share to investors purchasing the Common Stock in this offering.

We calculate dilution per share of Common Stock to new investors by subtracting the pro forma net tangible book value per share of Common Stock from the public offering price paid by the new investor. The following table illustrates the dilution to new investors on a per share basis:

For the table above the number of shares of Common Stock outstanding is based on 12,500,000 shares of Common Stock issued and outstanding as of December 31, 2023, and excludes the following shares:

● 849,301 shares of Common Stock underlying the assigned restricted share units and other awards under the 2020 Equity Incentive Plan as of December 31, 2023;

● 410,586 shares of Common Stock underlying the outstanding warrants and approximately 250,000 shares of Common Stock underlying the SAFE agreements;

● 2,059,349 shares of Common Stock that may be the subject of future awards under the 2020 Equity Incentive Award Plan as of December 31, 2023; and

● excludes up to 645,000 shares of Common Stock that may be sold to the underwriter pursuant to exercise of the over-allotment option and up to 430,000 shares of Common  Stock (494,500 shares if the over-allotment is exercised) which may be sold pursuant to the exercise of the warrants issued to the underwriter.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

Invizyne is a bio-technology, pre-revenue, development stage company, which is a majority-owned subsidiary of MDB Capital Holdings, LLC. Management believes that Invizyne’s technology is a differentiated and unique synthetic biology platform. Management believes the platform will enable scalable production of chemical molecules found in nature in a process that is alternative to and more environmentally friendly and sustainable than the typical methods used today, such as chemical synthesis, natural extraction, and synthetic biology. Invizyne believes its technology could significantly change biomanufacturing through leveraging cell-free, multi-step enzyme-based systems that will be able to efficiently transform natural or renewable resources into sought after chemicals. The objective with SimplePath,™ the Invizyne synthetic biology platform, as it is developed over time, for diverse range of select chemicals will enable the efficient production of pharmaceuticals, fuels, materials, food additives, and novel compounds.

Results of Operations

The Company has determined its reporting units in accordance with ASC (Accounting Standards Codification) 280, Segment Reporting. The Company has one reportable segment for Invizyne as a whole. A single management team that reports to the Chief Executive Officer comprehensively manages the business. Accordingly, the Company does not have separately reportable segments.

The Company’s consolidated statements of operations as discussed herein are presented below.

Consolidated Results of Operations for the Years Ended December 31, 2023 and 2022

Operating Income. For the year ended December 31, 2023 operating income was generated from one feasibility study conducted.

General and Administrative Costs. During the years ended December 31, 2023, and 2022, respectively, several factors contributed to changes in various expense categories:

Research and Development Costs. The increase in research and development costs for the current period was partially offset by increased grant funding. For the year ended December 31, 2023, total research and development costs were $3,481,688, with $2,954,208 reimbursed by grants, resulting in net research and development costs of $527,480. For the year ended December 31, 2022, total research and development costs were $2,689,540, with $2,312,857 reimbursed by grants, resulting in net research and development costs of $376,682. The increase in research and development costs was driven primarily by an increase in compensation due to the hiring of additional research and development staff, an increase in lab supplies expense, and an increase in grant sub-award expenses issued to a third-party research partner.

Consolidated Balance Sheet as of December 31, 2023 and December 31, 2022

Financial Condition: The increase in assets was due to changes in several asset classes. The increase in grants receivable was driven by the timing of collection of grant funds from the prior period. The increase in prepaid expenses and other current assets was driven by increased deposits. The increase in property and equipment was driven by the purchases of lab equipment. The increase in operating lease right-of-use assets resulted from the addition of additional office space during the period.

The increase in liabilities was primarily due to the increase in accounts payable as expenses increased from the prior year. The increase in due to affiliates was due to an increase in services and financial support provided by the parent company. The decrease in deferred grant reimbursement was driven by lab equipment purchases. The SAFE liability was generated through funds received from the parent company. The increase in operating lease liability was due to a new lease for additional office space.

The equity decrease was driven by an accumulated deficit generated by losses incurred from operations.

Liquidity and Capital Resources – December 31, 2023 and 2022

The Company’s consolidated statements of cash flows as discussed herein are presented below.

At December 31, 2023, the Company had working capital of $(1,201,680), as compared to working capital of $834,881 at December 31, 2022, reflecting a decrease in working capital of $2,036,561. The decrease in working capital during the period ended December 31, 2023 was primarily the result of decrease grant reimbursements over the year, the increase in accounts payable and the addition of a SAFE note. At December 31, 2023, the Company had cash of $66,533 available to fund its operation.

Operating Activities. For the period ended December 31, 2023, operating activities utilized cash of $1,180,870, which was driven by a combination of increased research and development activity, as well as increased general and administrative costs.

For the period ended December 31, 2022, operating activities utilized cash of $1,257,096, which was driven by a combination of increased research and development activity, as well as increased general and administrative costs.

Investing Activities. For the period ended December 31, 2023 and 2022, respectively, investing activities consisted of the purchase of laboratory equipment.

Financing Activities. For the period ended December 31, 2023 and 2022, respectively, financing activities consisted of investments from the parent company.

Recently Issued Accounting Pronouncements

See Note 2 in the consolidated financial statements for the discussion on recently issued accounting pronouncements.

Critical Accounting Estimates

The preparation of financial statements in conformity with general accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We have identified certain accounting policies as being critical because they require us to make difficult, subjective, or complex judgments about matters that are uncertain. We believe that the judgment, estimates, and assumptions used in the preparation of our unaudited consolidated financial statements and audited consolidated financial statements are appropriate given the factual circumstances at the time. However, actual results could differ, and the use of other assumptions or estimates could result in material differences in our results of operations or financial condition. Our critical accounting estimates are:

Valuation Allowance for Net Deferred Tax Asset

A valuation allowance is provided for deferred tax assets if it is more likely than not these items will either expire before the Company is able to realize their benefits, or that future deductibility is uncertain. At December 31, 2023 and 2022, the Company has established a full valuation allowance against all net deferred tax assets.

Accounting for Research Grants

Invizyne receives grant reimbursements, which are netted against research and development expenses in the consolidated statement of operations. Grant reimbursements for capitalized assets are recognized over the useful life of the assets, with the unrecognized portion considered a deferred liability and are included in accounts payable and accrued expenses in the consolidated balance sheet.

Grants that operate on a reimbursement basis are recognized on the accrual basis are revenues to extent of disbursements and commitments that are allowable for reimbursement of allowable expenses incurred as of December 31, 2023 and 2022, and expected to be received from funding sources in the subsequent year. Management considers such receivables at December 31, 2023 and 2022, respectively, to be fully collectable, due to the historical experience with the Federal Government of the United States of America. Accordingly, no allowance for grants receivable was recorded in the accompanying consolidated financial statements.

Research grants received from organizations are subject to the contract agreement as to how Invizyne conducts its research activities, and Invizyne is required to comply with the agreement terms relating to those grants. Amounts received under research grants are nonrefundable, regardless of the success of the underlying research project, to the extent that such amounts are expended in accordance with the approved grant project. Invizyne is permitted to draw down (a process of submitting expenses for reimbursement) the research grants after incurring the related expenses. Amounts received under research grants are offset against the related research and development costs in the Company’s consolidated statement of operations.

Stock Based Compensation

The Company and its subsidiaries may periodically issue common shares, stock options and restricted stock units to officers, directors, employees, and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.

The Company accounts for stock-based payments to officers, directors, employees, and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards.

The fair value of share options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the share option as compared to the fair market value of the common shares on the grant date, and the estimated volatility of the common shares. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical volatility of the Company’s common shares, calculated utilizing a look-back period approximately equal to the contractual life of the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value of the common shares is determined by reference to the quoted market price of the Company’s common shares on the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero. The fair value of performance based restricted stock units was determined by using an independent valuation expert.

On February 1, 2021, stock options to purchase 1,067,356 shares of Common Stock were granted at an exercise price of $1.22 per share, which was equal to the fair value of the Common Stock on the date of grant and are exercisable for a period of 7 years. The stock options vest ratably over a period of 5 years. As of December 31, 2022, stock options to purchase 409,158 shares of Common Stock have vested, the weighted average exercise price is $1.22, the aggregate intrinsic value is $0.00, and the weighted average remaining contractual term is 5.08 years for the year ended December 31, 2022. The unrecognized stock based compensation cost is being recognized on a straight-line basis of $667,552. There has been no change in inputs over the periods.

The fair value of each option on the date of grant was estimated using the Black-Scholes option-pricing model with the following assumptions:

Summary of Business Activities and Plans

Through this prospectus the Company plans to raise additional capital through its initial public offering. Funds from the offering will be used for development for general corporate and working capital requirements.

External Risks Associated with the Company’s Business Activities

Covid-19 Virus. The global outbreak of the novel coronavirus (Covid-19) has led to disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis.

The Covid- 19 pandemic has and may continue to impact the Company’s investments and potential investments, which could disrupt its business activities. The effects of various public health directives and the Company’s work- from-home policies may negatively impact productivity, disrupt the Company’s business activities, and delay timelines and future results, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on the Company’s ability to conduct business activities in the ordinary course. These disruptions, and perhaps more severe disruptions to the Company’s operations could negatively impact the Company’s business activities and results of operations and financial condition, including the Company’s ability to obtain financing. To date, the Company has not incurred impairment losses in the carrying values of its investments as a result of the pandemic and is not aware of any specific related event or circumstance that would require the Company to revise the estimates reflected in the consolidated financial statements.

In light of the uncertain and continually evolving situation relating to the spread of Covid-19, this pandemic could pose a risk to the Company. The extent to which the coronavirus may impact the Company’s business activities and capital raising efforts will depend on future developments, which are highly uncertain and cannot be predicted at this time. The Company intends to continue to monitor the situation and may adjust its current business plans as more information and guidance become available.

Inflation Risk. The Company does not believe that inflation has had a material effect on its operations to date, other than its impact on the general economy.

Supply Chain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities.

Potential Recession. There are various indications that the United States economy may be entering a recessionary period. Although unclear at this time an economic recession would likely impact the general business environment and the capital markets, which could, in turn, affect the Company.

The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance become available.

Trends, Events and Uncertainties

Other than as discussed above, we are not currently aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition in the near term, although it is possible that new trends or events may develop in the future that could have a material effect on our financial condition.

BUSINESS

Overview

Invizyne believes it has discovered and is developing a process that could significantly change biomanufacturing by means of leveraging cell-free multi-step enzyme-based systems that will be able to efficiently transform natural or renewable resources into sought after chemicals. We believe that our biomanufacturing platform, known as SimplePath™, will be an important alternative to the current methods of chemical compound production, which methods today are generally chemical synthesis, natural extraction, and synthetic biology. Our objective with SimplePath™ is to enable the efficient production of a diverse range of select chemicals that are used in pharmaceuticals, fuels, materials, food additives, for example. We believe that SimplePath™ not only can maximize the value of these chemicals but also will contribute to the development of novel chemical compounds that should open new markets and business opportunities.

Invizyne was established in 2019, and is a pre-revenue, development stage company. Our primary operational activities to date have been development of the SimplePath™ platform. Application of the platform and the range and type of potential products are largely still in the development stage. We have only produced certain potential products in a laboratory setting, producing only laboratory quantities. As such the platform has not been tested in terms of broader market acceptance or manufacturing both at introductory and commercial levels. Whether or not we can commercialize our platform and whether or not the potential products we currently have determined possible with the platform can be manufactured and sold at commercial levels, at this stage, is uncertain.

Our SimplePath™ Platform

Our SimplePath™ platform consists of a series of enzyme based biomanufacturing systems that leverage natural processes to perform complex chemical conversions that convert a starting material into a desired end-product. Each SimplePath™ system is composed of one or more “modules” which consist of one or more enzymes that work together to perform a defined biocatalytic conversion. While a module can operate independently, multiple modules can be coupled and designed to work together in a defined sequence. This sequencing of enzymatic steps is referred to as a “cascade” or an “enzyme cascade”. Each SimplePath™ system is comprised of several key parts (i.e. substrate(s), the substance on which an enzyme acts), enzymes, cofactors (a substance, other than the substrate, whose presence is essential for the activity of an enzyme), defined operating conditions, selected purification processes, and other system specific elements) that act together to produce one or more intended products.

The roots of the SimplePath™ platform trace back to a more than decade-long research endeavor at Professor James Bowie’s laboratory at UCLA, where the core innovations underlying the SimplePath™ platform were developed.

One of the most common methods of synthesizing new molecules is chemical synthesis. Chemical synthesis is the construction of complex chemical compounds from simpler ones. It is applied to all types of chemical compounds. This process is often expensive and environmentally damaging or polluting. Energy use, which is usually high in this process, is often a factor in determining the viability of making an end-product. Most chemical synthesis methods also produce significant waste and often use petroleum-derived chemicals to derive the end-product. Side products can be difficult to separate from the main product; although some by-products are welcomed if they have their own commercial viability. Chemical synthesis, also, may have long and complex production cycles.

Natural extraction, another common method of sourcing molecules, typically is inefficient, especially when the desired molecule is only found in small concentrations in a plant or other organism. Natural extraction processes can use large amounts of energy when compared to the end result achieved. Often, environmentally damaging solvents are used in the extraction process. Traditional methods of natural extraction typically generate substantial amounts of waste product, which presents issues of local pollution and waste management. There is often an issue of the purity of the end-product, and in many instances the purification process will damage or destroy the active agent being sought. Achieving industrial quantity is an issue in natural extraction. Using natural resources, such as plants, may actually result in over harvesting with consequences to biodiversity, damaging land resources, and local income and related societal issues.

Synthetic biology, another form of synthesizing new molecules, seeks to rewire a unicellular organism, such as yeast, using genetic engineering to produce the desired molecule end-product. This approach has some benefits over the other two methods mentioned above, but it has been more difficult than originally thought to realize the sought after end-product in a timely fashion and at a reasonable cost. The desired molecule using this method, is often toxic to the organism, especially as concentrations increase; as a result molecule yields tend to be low given competing processes within the organism. The intricate interactions and regulatory networks within cells (in essence, the complex and often interdependent series of control systems that orchestrate activities within a cell) make it difficult to predict and optimize the desired outcomes. There tend to be issues achieving long term yield and productivity using synthetic biology when production is scaled up and subjected to industrial conditions.

Companies working in the biobased industry are addressing the world’s environmentally and socioeconomically unsustainable dependence on petroleum, still the key feedstock, which is the raw material used to produce the final product, for a wide array of products. Developing chemical the raw material feedstocks from renewable sources and using catalytic chemistry to create high-value chemicals that replace petrochemical products, among others, is critical to help achieve global sustainability. Biofuels are a major focus of the biobased industry. The biobased industry, however, is expanding into additional sectors, such as agriculture, products using acrylic acid, food production and safety, cleaning products, lubricants, detergents, fertilizers and many other chemicals in common use today. Researchers and firms are increasingly focusing on the development, production and commercialization of bio-derived replacements for many basic chemicals that are commonly used in many industries. These replacements may even be “drop-in” direct substitutes for their petroleum-derived counterparts.

Invizyne believes it is developing a new technology process that we believe has the potential to change the way molecules are created in the future. In our laboratory, for the limited number of molecules that we have worked with to date, we believe our SimplePath™ platform performs the same conversions targeted by other cell engineering technologies. We believe that instead of using whole organisms to make biobased molecules, our platform uses only the specific enzymes that are involved in the multi-step biocatalytic process of making the molecule of interest. This discovery and understanding appears to simplify the biobased process of synthesizing a new molecule and eliminates many of the inherent limitations and bottlenecks of the legacy technologies. Although not yet tested by independent third parties, we believe for many products, the SimplePath™ platform and processes can be more efficient, less environmentally damaging or polluting, and more cost-effective than traditional methods, depending on the product that is being made. Although not yet achieved, based on our laboratory results, we also believe SimplePath™ is more predictable and can be scalable. We believe our technology has the potential to create the next generation of innovative biomanufacturing systems that leverage the power of enzymes, which we call Biomanufacturing 2.0.

We estimate that the potential applications of the SimplePath™ platform are many in addition to those that we are studying at present. In the pharmaceutical space, the platform could be used to produce new drugs. In the biofuel space, it could be used to produce cleaner and more efficient fuels. In the food space, it could be used to create new flavors and fragrances. In the industrials space, it could be used to produce less environmentally damaging or polluting and more sustainable industrial chemicals. Invizyne currently has focused its development efforts on two platform areas: pharmaceutical drug discovery and biofuels. In the drug discovery space, the Company is currently working to produce CBGA, the “mother cannabinoid” from which other cannabinoids are derived, along with other select downstream cannabinoids which could have potential applications as therapeutics. In the biofuel space, Invizyne is working to produce isobutanol, a four-carbon alcohol with a branched structure that can be used as a biofuel or as a building block to higher value downstream molecules.

Through our research and development, we believe that we have successfully demonstrated, in the laboratory setting, the feasibility of manufacturing chemicals using our SimplePath™ processes. On the basis of these achievements, we believe our processes can be scaled up to achieve commercial production capabilities. Once there is indication of proven manufacturing processes at commercial scale, for a particular chemical or set of chemicals, we believe that we will be able to enter the market to offer processes that will be able to meet the growing demand for sustainable, high-quality, chemical products.

Research and Development Grants 

We have received US government grants, particularly from the Department of Energy (DOE) for work related to isobutanol, upgrading alcohols, and cofactor development, and the National Institutes of Health (NIH), for work relating to cannabinoids. This funding has enabled us to advance our technology, to conduct research, to help us validate our processes, and to move forward the boundaries of scientific and technological advancement in our field.

We also have received grants from two non-government sources. One of the grants was from the Gates Foundation for work on terpene synthesis. Terpenes are a class of natural products that carry out a myriad of functions in biosynthesis. The grant amount was $50,000, and the work was completed at about the time of founding the Company. The second grant was from Shell GCxN, received in 2023, which is under the Shell Game Changer Award program. The grant was used for our work in isobutanol production research.

To date, the grants the Company has received have together totaled $12,906,307, since inception.

Commercialization Strategy

Our current, primary commercialization strategy is to collaborate with third parties to engage in aspects of product research, testing, marketing, manufacturing, and product distribution. Such collaborations will involve out-licensing our technologies. We believe that using such a commercialization strategy will allow us to reduce our capital requirements and accelerate development and market acceptance and development of the SimplePath^TM platform and processes. However, such a strategy will require us to locate and enter into advantageous agreements and maintain a collaboration relationship where we will likely have to continue to provide research and development and actively maintain and protect our patents and other intellectual property or obtain the use of intellectual property rights held by third parties. There is no assurance that this marketing strategy will achieve the results that we seek or that they will be maintained.

Opportunity for Cell-Free Multi-Step Enzyme Biocatalysis

Each SimplePath™ platform is composed of one or more “modules” which consist of one or more enzymes that work together to perform a defined biocatalytic conversion. While a module can operate independently, multiple modules can be coupled and designed to work together in a defined sequence. This sequencing of enzymatic steps is referred to as a “cascade” or an “enzyme cascade.” Each SimplePath™ system is comprised of several key parts (i.e. substrate(s) (the substance on which an enzyme acts), enzymes, cofactors (a substance, other than the substrate, whose presence is essential for the activity of an enzyme), defined operating conditions, selected purification processes, and other system specific elements) that act together to produce one or more intended products. We believe that the processes within the SimplePath^™ platform may efficiently convert select natural or renewable resources into sought-after chemicals that will be manufactured using more sustainable and environmentally friendly methods, while maintaining economic feasibility. As a result, when considering the full lifecycle of a chemical, especially when comparing against petroleum sourced products, the end-product can be more environmentally friendly.

We believe that our proprietary SimplePath™ platform represents a potentially transformative leap in enzymatic manufacturing. In the highly competitive enzyme industry landscape, Invizyne distinguishes itself with its patented processes and research and development efficiency. We believe that our technology can convert low-value, renewable feedstocks, such as sugars, into a spectrum of potentially higher value compounds, which may be used to produce a diverse range of sustainable products. By focusing on renewable resources, Invizyne has the potential to help reduce the use of petrochemicals in the chemical production sector. Invizyne’s SimplePath™ also may contribute to the development of novel chemical compounds that could catalyze the emergence of new products and markets.

Previous Technologies and Their Limitations

Traditional production of fuels and chemicals has predominantly relied on three primary technologies, natural resource extraction, chemical synthesis, and more recently, synthetic biology (SynBio). Each method carries potential benefits but also significant drawbacks and notable limitations:

Natural Extraction: Many beneficial chemicals used by humans, such as vegetable oils, ethanol, perfumes, and pharmaceuticals (e.g. morphine, and aspirin), originate from biological organisms. While these molecules can often be extracted from natural sources, many potentially useful chemicals are found in only trace amounts, depending heavily on crop yields, market demands, and geopolitical factors. Natural extraction is generally characterized as inefficient, especially when the desired molecule is only found in small concentrations in a plant or other organism. Natural extraction processes can use large amounts of energy. Often, environmentally damaging solvents are used in the extraction process. When traditional methods of natural extraction are used, the method typically generates substantial amounts of waste product, which presents issues of local pollution and waste management. There is often an issue of the purity of the end-product, and in many instances the purification process will damage or destroy the active agent being sought. Achieving industrial quantity is an issue in natural extraction. Using natural resources, such as plants, may actually result in over harvesting with consequences to biodiversity, damaging land resources, and local income and related societal issues.

Chemical Synthesis: To circumvent the limitations of natural extraction, chemists have developed sophisticated methods for building both natural and novel molecules from simple building blocks. It is applied to all types of chemical compounds. Chemical synthesis is one of the most common methods of synthesizing new molecules, and the chemical industry infrastructure is well established globally. One of the major advantages of chemical synthesis is that it is highly scalable. However, traditional chemical production methods often suffer from substantive drawbacks such as high energy consumption, extraordinary operating conditions such as high temperatures or pressures, use of large volumes of toxic solvents (resulting in toxic waste), use of imprecise non-natural catalysts resulting in inefficient reactions, requiring extensive purification and associated increased costs, and each step in the synthesis usually requires different reaction conditions, making the process cumbersome and expensive which is often a factor in determining the viability of an end-product. This process is usually environmentally unfriendly. Side products can be difficult to separate from the main product; although some by-products are welcomed if they have their own commercial viability. Chemical synthesis, also, may have long and complex production cycles.

Synthetic Biology/Metabolic Engineering: To provide alternatives to chemical synthesis and natural extraction, significant efforts have been made to engineer biological organisms to be able to convert simple biomass into valuable chemicals. Synthetic biology seeks to rewire a unicellular organism, such as yeast, using genetic engineering to produce the desired molecule end-product. This approach has some benefits over the other two methods mentioned above, but it has been more difficult than originally thought to realize the sought after end-product in a timely fashion and at a reasonable cost. So far, achieving commercially viable production has been challenging. The failure of SynBio approaches can be a combination of many issues, including difficulty in keeping the host microbe alive, especially if the desired end chemical product or intermediate chemicals are toxic to the cell, presenting a competing metabolism where other internal processes either cannibalize the starting material or the resulting chemical product for the cell’s own needs. These complications lead to long and uncertain development cycles, low yields, extraordinary costs, and high failure rates. Overall, SynBio’s economic viability remains challenging, with the cost structures being influenced by research, development, scale-up processes and expensive manufacturing. The collapse of SynBio industry stalwarts like Zymergen, Demetrix and Amyris is exemplary of these risks.

Our Solution

The Invizyne SimplePath™ platform, we believe, is a distinct and potentially more effective path to less polluting, more environmentally manufacturing systems. Rather than engineer enzyme systems to produce a desired molecule within the context of a cell, as in SynBio, our approach avoids the complexity of the cell and the need for maintaining cell viability. After characterizing the necessary enzymatic pathway needed to make a selected molecule, we begin by isolating the desired enzyme catalysts for our SimplePath™ systems from cells, such as yeast, e.coli and picchia, then we place the desired mix of enzymes in a bioreactor, along with the feedstock (the basic raw material for the desired product), cofactors (a substance, other than the substrate, whose presence is essential for the activity of an enzyme) and other proprietary elements required to make the desired product.

The vast number of identified enzymes and enzymatic pathways, when combined with our expertise in enzyme engineering and pathway design, offer a myriad of tools to undertake biobased manufacturing. Moreover, Invizyne’s SimplePath™ platform offers potential access to chemical conversions that might be difficult from traditional cellular pathways or synthetic chemistry.

We believe our technology has the potential to overcome the inherent limitations and bottlenecks of the currently used legacy technologies. We think SimplePath™ can enable the building of complex enzymatic pathways that may operate with exceptional efficiency for long periods of time, thereby producing sizable concentrations of the desired product at high purity, at a manageable cost.

We believe our approach enables:

Current Lead Applications of SimplePath™

Although the bio-based molecule market is extensive and while we believe we have developed a large library of biomanufacturing systems using the SimplePath™ platform, our most advanced systems are in the areas of cannabinoids as active pharmaceutical ingredients (APIs) and the development of better biofuels for the energy transition space.

Drug Discovery - Cannabinoids as APIs

Cannabinoids represent a broad class of plant-derived natural products that are attracting increased attention for therapeutic applications. Cannabinoid molecules target the CB1 and CB2 receptors and modulate nervous system and inflammatory responses relevant to human health. The escalating demand for these cannabinoids, driven by their potential therapeutic capabilities, placed their market value, we believe, at an estimated $51 Billion¹ in 2023, with the therapeutic segment valued at approximately $13 Billion² in 2023. Additionally, we anticipate that regulatory shifts, both domestically and abroad, will increase both access and demand for these bioactive compounds, especially when produced at high purity levels and with consistent quality.

Despite their demonstrated and potential use as pharmaceuticals, widespread study and use of cannabinoids, especially rare cannabinoids, has been hampered by low purity and substantial production costs from plant sources, particularly for rarer cannabinoids – problems that are amplified by the variability of plant sources which are dependent on wind, weather, and soil conditions. Designed, new-to-nature cannabinoids with potential therapeutic benefits cannot generally be produced in plants.

Some natural cannabinoids can be produced at sizable concentrations in plants (e.g. CBD, THC) and therefore can be isolated from the plant for use in various products. Other potentially useful natural cannabinoids are only present in low concentrations within plants and are therefore expensive or impractical to produce by extraction. Moreover, designed cannabinoids with potential therapeutic attributes cannot be generated within plants. The complexity of these important natural molecules makes traditional chemical synthesis both challenging and costly. We believe that there is a significant market opportunity for platforms that can reliably produce new to nature, common, and rare natural cannabinoids at high yield directly from accessible and abundant resources.

Invizyne’s efforts have focused on devising a versatile, modular enzyme system capable of producing an array of cannabinoid compounds from cost-effective inputs. We believe that the adaptability of our approach allows the rapid production of diverse cannabinoids. Furthermore, our innovations in enzyme development, we believe, allows us to create new-to-nature cannabinoids, which can be tested for treatment of specific indications, more efficiently through engineered substrate preference and enhanced stability. While we believe our methods have broad applications, including in consumer cannabinoids, Invizyne’s core focus remains the generation of a diverse range of natural and novel compounds intended for therapeutic uses as active pharmaceutical ingredients.

Invizyne’s SimplePath™ cell-free approach for cannabinoid production distinguishes itself from other technologies by marrying the precision of biological production with the scalability of conventional chemical synthesis (exceptional titers, reliable scalability). Specifically, our method has demonstrated consistent performance even when scaled over 10,000x. Our cannabinoid biosynthesis platform not only employs a highly efficient enzyme pathway distinct from the one found in the Cannabis plant but also facilitates the production of sizable batches of both common and rare cannabinoids from reaction volumes of 100 liters (L) or less, ensuring greater than 99% purity, at a feasible cost. Importantly, the inherent modularity of our SimplePath^™ system provides flexibility, allowing us to make diverse cannabinoids by simply altering a single enzyme or feedstock chemical.

¹ https://www.statista.com/outlook/hmo/cannabis/worldwide

² https://www.statista.com/outlook/hmo/cannabis/therapeutic-cannabis/worldwide

Energy Transition – Better Biofuels

Commodity chemicals and fuels are principally sourced from petroleum. However, the extraction and refining processes of petroleum are energy-intensive, and its products have been identified as contributing to global warming. Efforts to implement SynBio solutions to replace petroleum-based chemicals with bio-based chemicals produced in engineered cells have largely failed as toxicity and competing metabolism have stymied efforts to optimize yield and productivity, which is particularly problematic for commodity chemicals where cost is critical. To our knowledge, no next-generation biofuel (beyond ethanol) has been economically produced using engineered cells. Thus, the production of biofuels and commodity chemicals represents a stringent test and very large opportunity for Invizyne’s technology.

Specifically, we have applied Invizyne’s technology towards the production of isobutanol, an industrial chemical that can be sold as a specialty chemical or a value-added next generation fuel blend stock. Our innovative SimplePath™ system for isobutanol converts biomass-derived sugar (e.g. glucose) into isobutanol through a sequence involving 16 enzymatic steps. Certain advantageous characteristics and technical properties of SimplePath™ for isobutanol, and properties of the isobutanol molecule itself as compared to legacy biofuels include the following:

The results from SimplePath™ for isobutanol demonstrates that enzyme systems can be developed for complex transformations that are highly robust, with what we anticipate to be commercially viable production parameters.

Accordingly, we believe that our technology can efficiently and sustainably produce chemicals that substitute for petroleum-derived products while remaining competitively priced. We believe that we are poised to enter into the growing sustainable aviation fuel, or SAF, market, which is expected to reach 3 billion gallons by 2030 and 23 billion gallons in 2050 of U.S. market penetration, as outlined by the multi-agency issued initiative “SAF Grand Challenge Roadmap” which supported the U.S. Inflation Reduction Act.. Global SAF use is currently being supported and mandated by multiple governments of countries other than the U.S. mostly in Europe and other developed economies

Given its advanced and more desirable fuel properties, isobutanol could potentially replace in the future a significant portion of the existing ethanol market, which was approximately 28 billion gallons in 2022, and could potentially expand the market due to more and higher value uses (https://www.statista.com/statistics/274142/global-ethanol-production-since-2000).

Additionally, isobutanol can serve as a versatile chemical feedstock (raw material) for various industrial applications, including the production of plastics, solvents, and other chemicals. Isobutanol can be converted into butenes, which are the primary hydrocarbon building blocks used in the production of hydrocarbon fuels, lubricants, polyester, rubber, plastics, fibers, and other polymers. Its direct application as a solvent in the manufacture of amino resins, isobutylamine, acrylates, and methacrylate further accentuates the significance of isobutanol. While the market for isobutanol is nascent, related chemicals like n-butanol represent a volume of approximately 5.5 million metric tons and a market valued at many billions of dollars (https://www.statista.com/statistics/1245211/n-butanol-market-volume-worldwide).

We believe that isobutanol represents an attractive target market, both from economic and environmental perspectives. We are currently in discussions with several leading entities in the chemical manufacturing sector, aiming to collaborate and further push the boundaries of what is achievable in this space. We believe our isobutanol SimplePath™ technology has the potential to scale and produce isobutanol at commercially relevant metrics and economics, while offering a less environmentally damaging and polluting alternative to petroleum-derived products. Our energy efficient process is expected to integrate easily into existing infrastructure using standard processing equipment that is readily available.

Our Business Model

We are a pre-revenue, development stage company focused on technology and IP development without a history of manufacturing, product development, or marketing endeavors. Given the intricate nature and potential costliness of establishing manufacturing facilities for both commodity and specialty chemicals and bringing them to market across a spectrum of industries, our commercialization approach is designed to maximize the value of our SimplePath™ platform for biomanufacturing.

Our current focus is to develop complete SimplePath™ systems, which we refer to as CSS, that are embodied in a tech-transfer package addressing the process from feedstock selection, to manufacturing, to an end-product that is ready to sell or be used. Once a CSS is fully developed, we will monetize the CSS by licensing arrangements, development of joint ventures, and creation of new purpose driven subsidiaries or affiliates focused on executing specific CSSs. We intend to be flexible in the variety of value sharing mechanisms, including royalties, equity, and lump-sum commercial milestone payments, and we are generally agnostic on which form of downstream value capture we receive. A CSS may be used to launch a new company by bringing together a business purpose, production platform, and technical and management advice and participation with strategic and financial investors to fund an early stage company. We believe that we are able to leverage our technology expertise, the SimplePath™ platform for biomanufacturing, business acumen and investor base to enable companies at all stages to benefit from our experience and provide a backbone for new business development.

We plan to prioritize the development of a CSS when we have confidence that a valid business case exists for the particular end-product, and where we believe there is a distinct advantage for our cell-free biomanufacturing process to overcome the challenges presented by other technologies such as product toxicity, product yield, product isolation, or a needed solution that is less polluting or environmentally damaging. We also will prioritize the development of CSSs where we may control the essential elements in manufacturing and supply chain strategies, and where we hold and control the foundational IP for such systems.

In essence, our approach transcends mere product creation and is envisioned to revolve around embedding innovation at every stage, fostering collaborations, and ensuring that our offerings resonate with industry needs, all while championing sustainability and efficiency. We believe that our dynamic approach will create opportunities for better than average returns as our partners, by whatever means, successfully commercialize products built using our platform and drawing on our expertise. If we are able to add and multiply programs, we expect that downstream value sharing to contribute income and improve overall margins and cash flow.

As an example of our business model approach, we have entered into an agreement to form, in the future, a joint venture with Neuractas Therapeutics, a preclinical pharmaceutical company, located in Ontario, Canada, with the intended purpose of developing high impact therapeutics and to work with the Company on deuterated cannabinoid molecules (“d-CNS”). As a preliminary step before the joint venture will be formed and finalized, the Company conducted some research and is developing a provisional patent relating to its process to create the d-CNS. The purpose of the joint venture will be to operate as a for-profit enterprise engaged in the sale and/or licensing of products developed by the joint venture within the defined markets. The joint venture will itself, or arrange for others to, test, study, manufacture, license and otherwise commercialize the joint venture products. The Company will develop the methods to make and manufacture the required molecules and provide a specified quantity of the molecules, and Neuractas will undertake the metabolism studies and also will be responsible for initiating and pursuing the regulatory proceedings for obtaining a pre-IND opinion from the FDA on development plans for potential products. When operational, Neuractas will lead the business development efforts with the customers of the joint venture with the goal of commercializing or otherwise selling or licensing commercial rights for the development of dTHC, dCBD and other d-CNS. Each participant in the joint venture will be responsible for its own costs, and will determine jointly the joint venture management, administration, business plan and funding. The joint venture will be jointly owned, 50% for each party, however the ownership of certain of the intellectual property, once developed, will be allocated differently, as the parties agree. To date, the Company has not expended any substantial funds in relation to the planned joint venture, other than a limited amount in relation to preparation for filing for a provisional patent application and making research quantities of certain d-CNS. No assurance can be given that a joint venture will be formed in the final analysis, or that if formed it will be able to successfully carry out the intended purposes.

Intellectual Property

We believe Invizyne’s inventions cover a wide range of technologies that relate to biomanufacturing. These inventions include new chemical entities, composition of matter IP on novel and engineered individual enzymes with changes in stability, activity, specificity, or a combination thereof, as well as systems of enzymes designed for pioneering novel manufacturing processes. Additionally, our inventions include cofactor and metabolite management optimized for sustained reaction continuity, and advancements in enzyme expression strains and processes. We protect our technological edge through a combination of patent applications, trade secrets, and professional know-how that only may be known by a subset of our corporate organization. At present, Invizyne has a portfolio of patents and patent applications, filed in the United States. Additionally, we have several other invention disclosures and proprietary trade secrets. Included in our patent portfolio, is a license for a suite of patents from University of California Los Angeles (UCLA), which safeguard different aspects of co-factor regeneration, cannabinoid biosynthesis, and engineered enzymes. We believe that our consolidated portfolio provides a defensible position that enables the creation of complex, robust, sustainable enzyme systems.

To provide a defensible position and foster the creation of complex, robust, sustainable enzyme systems, we intend to further develop IP that will target the following domains:

The current patents licensed by and owned by Invizyne are as follows:

Key terms of the license agreement with UCLA

On April 26, 2019, we entered into a licensing agreement with The Regents of The University of California. This agreement pertains to certain patent rights, notably encompassing: (i) pathway designs for the balance of co-factors in a cell-free system, and (ii) cell-free platform for the prenylation and a designed enzyme for cannabinoids biosynthesis. We hold a worldwide exclusive license to the valid claims of the patents held by The Regents and a non-exclusive license to the associated technology, with the right to sublicense, import, make, have made, use, provide, offer to sell, and sell all products derived from the technology covered by the license agreement. The licenses extend to affiliates of the Company. The Regents have retained the right for itself to use the patents for educational and research purposes, publishing and performing clinical diagnostic and prognostic services of its healthcare system.

The initial license fee was $6,000 and the continuing license maintenance fee is $2,500 per year. The license requires a minimum annual royalty, initially in the amount of $15,000 rising to $50,000 starting the third year of the license. Invizyne is to pay The Regents a royalty on the net sales of licensed products equal to two percent with respect to therapeutics products, and one percent with respect to all other products, payable quarterly. To date, the Company has not developed products that have generated net sales on which a royalty is due. Invizyne is also to pay an initial sublicensing fee equal to 15% which falls to eight percent. There are additional milestone payments due based on net sales equal to $250,000 on the first $1,000,000 of net sales of an initial licensed product and then $350,000 when a second licensed product has $2,000,000 of net sales. To date, we have not paid any royalties to The Regents, they are due approximately $1,000. Invizyne also issued four percent of its Common Stock to The Regents. The Regents have entered into a one-year market stand-off agreement with respect to its shares of Common Stock in connection with this offering.

Invizyne is required to use commercially reasonable efforts to achieve specified development milestones. If these are not achieved then The Regents has the right and option, at its sole discretion, to either terminate this Agreement or reduce the exclusive license to a nonexclusive license. We believe we have met the several milestones, and retain the license on the exclusive basis. The term of the license is for 10 years after the first commercial sale of a licensed product that triggers an earned license fee. We are required to carry specified levels of insurance, maintain certain records and provide copies to The Regents of specific reports, and provide for certain ongoing patent costs.

Regulation

As Invizyne continues to develop and optimize the SimplePath™ systems to make its products for use in the pharmaceutical and biofuels industries, these products will require the Company to address regulation of different kinds. Depending on particular product development and marketing pathway, we may have to address regulatory compliance ourselves or we may be able to require a third party licensee to undertake meeting the regulatory requirements of our product as a stand-alone licensed product or in conjunction with their own product.

Cannabinoid Regulation

The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of biologics such as those that we may develop. We, or third-party contractors or licensees, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the United States and other countries for which we wish to conduct studies or seek approval of our product. Companies involved in the production of pharmaceuticals are also subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. Such laws include, without limitation: the federal Anti-Kickback Statute (“AKS”); the federal False Claims Act (“FCA”); the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and similar foreign, federal and state fraud, abuse and transparency laws.

Even where the particular product is only to be used topically or in edible products, the Federal Food Drug and Cosmetic Act, extends regulation to foods, dietary supplements, cosmetics and veterinary products. Cannabinoids are used in a variety of topically applied lotions, salves, oils, sprays and transdermal patches. Cannabinoids are also found in products that one eats. State regulation in about half of the states of the United States extends to a variety of product attributes that include cannabinoids, including (i) the percentage of a cannabinoid that may be included in these kinds of products, (ii) warning labels, (iii) restrictions on packaging to protect children and child resistant packaging, (iv) application of general food safety regulations, such as food production, packaging and handling, (v) prohibitions on the kinds of products that can contain or be infused with cannabinoids, and (vi) the appearance of products that contain cannabinoids. Some forms of synthetic cannabinoids have been banned from being used in connection with human intended products.

New small molecule compounds that go into foods or are used as dietary supplements, which have health claims attached, are subject to regulation as set forth in the U.S. Dietary Supplement Health and Education Act of 1994. The FDA does not approve dietary supplements, but it does regulate them for safety. As such, regulation would be under various FDA requirements and the New Dietary Ingredient notification process. However, if the molecule compounds are used in cosmetics, it does not require FDA approval prior to going to market, which is the same as for dietary supplements, as long as they have been tested for safety.

Specifically relating to tetrahydrocannabinol (THC, the gem dimethyl cyclized ether of cannabidiol specifically with a 5 carbon alkyl chain on the resorcyclic acid moiety) and its derivatives, per 21 C.F.R. § 1308.11(d)(31) (7), if the small molecules are derivatives of THC, they may be subject to federal regulations. As such, this would require any such derivatives to follow the FDA Drug Development schedule for Clinical Trials. The FDA regulatory pathway for drugs would govern activities related to these compounds. However, if the compounds are not tetrahydrocannabinol analogs (e.g. the alkyl chain is less than 5 carbons or the compound contains a different cyclization pattern), then they would likely be subject to regulations set forth in the 2018 Farm Bill (and/or the U.S. Dietary Supplement Health and Education Act of 1994). For example, tetrahydrocannabivarin, which is a THC analog but with a 3 carbon alkyl chain instead of a 5 carbon, may or may not be subject to the 2018 Farm Bill if it is made synthetically as opposed to being extracted from the hemp plant.

The FDA and congress are continually updating their cannabis and cannabinoid policies, so we believe that regulations are likely to change. Other uses that are likely not subject to regulation (as long as it is not a THC analog as described above) by the FDA are cosmetics, supplements, and dietary aids as long as there are no health claims associated with the product, and they are safe as described above (or it is not a cosmetic/topical drug). Where cannabinoids are used as analytical standards or research aids, these would also not be regulated.

BioFuel Regulation

Numerous pieces of Federal legislation impacting the oil and gas industries have been passed by Congress over the last many decades. Some of these statutes include (i) the Interstate Commerce Act of 1887 that regulates interstate transportation of fuels, (ii) the Energy Policy Act of 2005 that outlines the incentives and benefits for oil and gas producers that help make the United States energy self-sufficient and also establishes the renewable fuel standard (RFS) program where gasoline must be blended with renewable fuel, (iii) the Clean Air Act, the Clean Air Act Amendments of 1990 and the Clean Air Act Extension of 1970, and subsequent amendments, dictate fuel standards, including banning leaded gasoline, and (iv) the Energy Independent and Security Act of 2007 that expanded the renewable fuel standard (RFS) program, in addition to increasing fuel economy standards. The Environmental Protection Agency (EPA) currently administers the RFS to impose an annual minimum volume of biofuels based on the estimated total volume of transportation fuels. Since the RFS indirectly subsidizes capital investment in the construction of biofuels plants, the RFS is expected to continue to stimulate and shape growth in the biofuels industry.

Governments at different levels in the United States have introduced various support policies to promote alternative and renewable energies. These policies aim to reduce greenhouse gas emissions and to improve energy security. Major policy initiatives include biofuel mandates and tax credits. It is widely expected that these policies will significantly affect both the environment and the economy of the United States. For example, biofuel production has effectively changed the role of agriculture by creating a linkage between the agricultural and energy sectors. Economic research indicates that the biofuel mandate has significantly affected agricultural commodity prices, which has caused a structural shift in land use and crop production.

For biofuel to be sold in the U.S. market, the fuel must meet certain quality specifications. In the United States, biofuel must meet the American Society for Testing and Materials (ASTM) requirements for biofuel fuel. There are similar standards in Europe. Additionally, standards and regulations also address safety related issues, which is in part under the purview of the Occupational Safety & Health Administration. All these standards, however, are in constant development and change, and are challenging the means of analysis, grouping and standardization. Biofuels have significantly different chemical compositions from hydrocarbons, which means different physical and fuel properties. Where hydrocarbon fuels have a very extensive system of industrial standards and testing, biofuel standards and testing methods are still are being developed. Because biofuels are being created and developed at such a rapid pace and with ever greater complexity, the standards, testing and regulation is constantly evolving to keep up.

The properties of biodiesel, for example, depend on several factors, including the feedstock and the refining process. Producers who follow standard procedures to make the fuel, such as those of the Biodiesel Production Principles and Processes Guidelines and the ASTM, will have a better chance of producing fuel that meets the specifications for sale and use. The standards generally focus on (i) flash point, (ii) water and sediment, (iii) kinematic viscosity, (iv) sulfated ash, (v) sulfer, (vi) corrosion, and (vii) combustion, along with a significant number of additional criteria. Similar to biodiesel purchasers of other biofuels will also require testing and adherence to public standards and their own requirements and test their purchased biofuel product for meeting the various standards that exist and that may be established. For example, these standards are meant to provide quality specifications so that there are no adverse consequences from their use or inclusion in another form of fuel such as severe as engine seizure, filter plugging, and adverse emissions. It is expected that safety standards will also predominate regulation as biofuels gain use in more fuel products or energy supply systems.

As biofuels are developed and successive generations of production processes and products are created, we expect that environmental sustainability issues will be addressed and regulation will evolve. Biofuels are being promoted as a low-carbon alternative to fossil fuels as they could help to reduce greenhouse gas emissions and the related climate change impact from transport, among other uses. However, as there are concerns that their wider deployment could lead to unintended environmental consequences, it is expected that policies and forms of regulation or incentives will emerge to evaluate, monitor and control the broader impact of their use. To date, the findings about the impact and benefits of biofuels are often conflicting, with a wide variation in their conclusions. We believe that the studies and findings are highly situational and dependent on many factors, including the type of feedstock, production routes, data variations and methodological choices. Currently, there are studies that show that reductions in greenhouse gas emissions from biofuels are achieved at the expense of other impacts, such as acidification, eutrophication, water footprint and biodiversity loss. These will have to be addressed as the industry evolves, and processes will have to be developed to address these issues.

Competition

We believe Invizyne stands at the forefront of multi-step biocatalytic system development for the production of diverse chemicals. While enzymes are commonplace in a variety of industrial processes, we believe the uniqueness of Invizyne’s technology lies in its ability to build complex, yet robust and efficient, enzyme systems.

Considerable efforts have been, and are being, devoted to engineering living organisms to produce useful chemicals ranging from high-value natural products like cannabinoids to commodity products such as, fuels, plastics, and building block chemicals. Given the broad and growing attention to the environment and the environmental benefits of synthetic biochemistry, many players are attracted to the industry. Currently, there are many companies in the synthetic biology market, including, well known firms operating on the industry segments of life science and biology solutions, pharmaceuticals, meat, beauty, agriculture, automobile, and fashion. The number of companies and scope of industry segments touched upon demonstrate that this is an active, developing industry.

We believe that we will face competition from many companies and research institutions that are currently working in, and will enter, the industry to work on the many aspects of cell-free synthetic biochemistry. Debut Biotech and Solugen Inc. promote the advantages of cell-free enzymatic systems over cell-based systems, but their processes appear to use simple one to two step pathways. Codexis, Inc. partnered with Tate & Lyle and Merck & Co., Inc. on different, highly specific projects that use multi enzyme pathways, such as enzymatic Islatravir synthesis, illustrating the potential for complex enzyme cascades, but their principal mission diverges from the enzymatic manufacturing of more general chemicals. There are many companies that focus on enzyme engineering, such as Codexis, Inc., Allozymes Pte Ltd. (Singapore), Enzymit Ltd. (Israel and US), Zymtronix Catalytic Systems, Inc., Arzeda Corp. and Quantumzyme LLP (India). There are other companies that develop enzyme immobilization technologies. There are a number companies operating in the biofuels space, such as Valero Energy Corporation, ADM Corporation, Cargill Company, Gevo, Inc. and Butamax Advanced Biofuels LLC that focus on ethanol technologies.

Additionally, we believe that we will also compete against the numerous companies around the globe that dominate particular markets and segments for products made or sourced using synthetic chemistry or via natural extraction.

We believe that a majority of the companies that present some aspect of competition are well established companies that have more experience identifying and carrying out the scientific development required of products that will be competitive to those of Invizyne. Many of these companies have, and others that we anticipate entering the market in the future will have, greater financial and management resources, brand or science name recognition or industry contacts than we possess. A number of the companies are multinational companies and many are also publicly listed companies, with large market capitalizations.

We believe that we compete with those firms based on a number of factors, including

We also believe we compete based on our unique technological approach. We believe our scientific approach and technology is not as specialized as those of our competitors, thereby opening product pathways for a plethora of more diverse chemical manufacturing applications. We believe that our intellectual property on recycling of essential cofactors will allow us to efficiently operate extensive multistep processes outside of a living cell. This represents a competitive advantage over traditional synthetic biochemical companies. In the biofuels sector, we do not compete directly with ethanol producers because our primary target, isobutanol, is widely regarded as a superior biofuel. 

Employees and Facilities

Invizyne’s forward-looking strategy anticipates upscaling in terms of both personnel and manufacturing capabilities. We expect our expansion will span our operational segments, including business development, research and development (R&D), fermentation, and pilot-scale production.

Employees

As of March 30, 2024, Invizyne boasts a dedicated team of approximately 29 full-time employees or equivalents. Among them, 11 hold doctoral degrees. Nineteen employees focus on R&D efforts, four are dedicated to pilot projects, while the remaining six concentrate on business development, finance, and general administration. In addition to expanding our business development efforts, Invizyne plans to expand both R&D and manufacturing scaling efforts, which will require us to bring on new hires in multiple departments. These hires will be responsible for sales efforts, pioneering processes, innovations, and ramping up production scales.

None of our employees are affiliated with labor unions or are part of a collective bargaining agreement. We believe we have a positive and harmonious work environment and our employee relations are good.

Facilities

Our headquarters and R&D facilities are currently located in Monrovia, California. We lease approximately 10,000 square feet of recently renovated space at a current monthly rent of $28,007, on a full service gross lease basis. Of the total space, approximately 1,200 square feet currently is reserved for R&D pilot activities and supporting the scaling of reactions up to 100 liters in size, and the balance of the space is split among the general and administrative office, R&D laboratory requirements, fermentation uses to develop and produce needed enzymes, and to house an analytical lab.

In the future, as we grow our business, we anticipate leasing additional space for (i) increased enzyme production to support R&D and manufacturing scale up efforts (Fermentation Facility), (ii) a pilot production facility dedicated to the production of commodity chemicals with an initial focus on isobutanol (TPP Industrials), and (iii) a pilot production facility, envisioned to be built and operated as a current Good Manufacturing Practices facility, dedicated to the development of APIs with an initial focus on cannabinoids (TPP APIs). We believe that we should be able to lease space on terms similar to those of our current facility in Monrovia, CA that we believe will be in line with other commercial properties currently available.

By developing the Fermentation Facility and the two distinct TPP facilities, it is our plan to create a flexible process that could enable us to tap into diverse market opportunities and refine them to a level of a comprehensive, turnkey CSSs. As an alternate to building the TPP facilities, this requirement can be complemented by leveraging the facilities of Contract Manufacturing Organizations (CMOs) and collaborative partners.

Legal Matters

We are not currently subject to any material legal proceedings. However, we may from time to time become a party to various legal proceedings arising in the ordinary course of our business.

MANAGEMENT

Set forth below are our directors and officers:

Michael Heltzen. Mr. Heltzen has served as the Chief Executive Officer of the Company since February 1, 2024 and previously served as the Chief Strategy Officer of the Company from October 2023 to January 2024. Prior to joining the Company, Mr. Heltzen held the position of Executive Vice President for Strategy at Paragraf Ltd. from May 2023 to October 2023. From January 2019 to May 2023 Mr. Heltzen served as the Chief Executive Officer of Cardea Bio Inc. Mr. Heltzen also served as the Chief Executive Officer and Chairman of Nanosens Innovations Inc., prior to its merger with Cardea Bio Inc., from December 2018 to September 2019. Mr. Heltzen has also served as the Chairman of the Board for EXO Incubator Inc since 2015 and Chairman of the Board for Blue SEQ Innovations Inc. since 2010.

Fouad Nawaz. Mr. Nawaz has served as the Vice President Finance of the Company since September 2023. Prior to joining the Company, Mr. Nawaz served as the Vice President of Finance at Fulham Co Inc. from June 2018 to September 2023. Mr. Nawaz received his Bachelor of Science degree in 2007 in Business administration from California State University, Long Beach.

Tyler Korman, PhD. Dr. Korman has served as Vice President of Research effective as of February 1, 2024 and previously served as Director of Research and Development of the Company from August 2019 to January 2024. From June 2014 to September 2019 Dr. Korman was a Project Scientist in the Department of Chemistry and Biochemistry at the University of California, Los Angeles. Dr. Korman received his PhD in Molecular Biology and Biochemistry from the University of California, Irvine in 2008, Master of Science in 2003 and Bachelor of Science in 2001 in Chemistry from the University of California, San Diego.

Paul Opgenorth, PhD. Dr. Opgenorth has served as Vice President of Development effective as of February 1, 2024 and previously served as Director of Research and Development of the Company from August 2019 to January 2024. From May 2017 to August 2019 Dr. Opgenorth was a postdoctoral scientist in the Joint BioEnergy Institute at Lawrence Berkeley National Lab. Dr. Opgenorth received his PhD in Chemistry, Biochemistry, and Structural Biology from the University of California, Los Angeles in 2015, and Bachelor of Science in 2004 in Chemistry from the University of California, Davis.

Mohammad “Mo” Hayat. Mr. Hayat has served as the Chairman and Chief Executive Officer of the Company since its inception in April 2019, and, effective as of August 2022, transitioned to the role of Executive Chairman, President and Interim Chief Executive Officer of the Company. Effective as of February 1, 2024, Mr. Hayat transitioned to the role of Chairman of the Board and President of the Company. Mr. Hayat also serves as Chief of Entrepreneurship & Operations of MDB Capital Holdings, LLC since its inception on August 10, 2021, and a director of MDB Capital Holdings, LLC since January 14, 2022. Mr. Hayat founded and has operated Mora Partners Inc., a consulting and investment firm since September 2006. Notable prior experiences for Mr. Hayat include serving as an Associate at Latham and Watkins from 2001 to 2006, as Partner at Raines Law Group from 2006 to 2009, as EVP of Business Development at Fulham Company Ltd from 2009 to 2015, and as Associate General Counsel Corporate, M&A, and Venture Capital at Hewlett Packard Enterprise from 2015 to 2017. Mr. Hayat also served on the board of directors of Fulham Company Ltd. from January 2019 to August 2022. Mr. Hayat received his Juris Doctorate in 2001 from UC Berkeley School of Law and a Bachelor of Science in Biological Chemistry in 1997 from Pepperdine University. The Board believes that Mr. Hayat’s educational attainments, managerial and investment banking expertise, combined with his leadership role at the Company since its inception, qualify him to serve as the Chairman of our Board.

James U. Bowie, PhD. Dr. Bowie has served as a director of the Company since its inception in April 2019. Dr. Bowie has been on the faculty in the Department of Chemistry and Biochemistry at the University of California, Los Angeles since 1993 and served as Associate Director of the UCLA-DOE Institute from 2002 to June 2019 and Vice Chair from 2012 through June 2019. He became Professor Emeritus in June 2021. Dr. Bowie served on the Editorial Boards of four academic journals, organized many international meetings and served on numerous national and international scientific committees, including service as President of the Protein Society from 2013 to 2015. Dr. Bowie obtained a B.A. with Distinction in Chemistry from Carleton College in 1981, a Ph.D. in Biochemistry from the Massachusetts Institute of Technology in 1989 and did postdoctoral work at the University of California, Los Angeles from 1989 to 1993. His work has been cited over 29,000 times and has been recognized with many awards, including being named Fellow of the Biophysical Society and Fellow of the American Association for the Advancement of Science. Throughout his career, Dr. Bowie’s work has focused on issues related to protein and enzyme structure. He holds patents on drug screening technology, methods for protein structure prediction, and for enzyme system design. The Board believes that Dr. Bowie’s intimate knowledge of Invizyne’s foundational enzyme technology will be highly valuable to our Board’s deliberations and oversight of Company strategies.

Christopher Marlett. Mr. Marlett has served as a director of the Company since its inception in April 2019. Mr. Marlett has been the chief executive officer and chairman of the board of directors and a director of MDB Capital Holdings, LLC since inception on August 10, 2021. Mr. Marlett has been since 1997, the Chief Executive Officer and a co-founder of Public Ventures (formerly known as MDB Capital Group, LLC). Over his 36 years of working in the securities industry, he has led multiple financings for venture stage public companies and has dedicated his efforts to optimizing this method to launch promising technology/business platforms. He has been integral in co-founding and developing the commercialization and financing strategy for all the companies MDB has taken public. In addition, he has served as a board member of several of the public companies in the early stages. He has invested significant efforts in developing a human capital development platform in Nicaragua that has led to the creation of the largest call center park in the country employing approximately 3,000 people and several knowledge process outsourcing operations to support MDB’s businesses. He developed the first patent services company in Nicaragua that was sold to Murgitroyd an LSE-listed patent attorney and services platform. He is the co-founder of PatentVest and developed the platform from inception in 2003. He holds a Bachelor of Science degree in Business Administration from the University of Southern California. Mr. Marlett’s leadership and extensive corporate and financial experience position him well to serve as a member of our board of directors.

Anthony DiGiandomenico. Mr. DiGiandomenico has served as a director of the Company since its inception in April 2019. Mr. DiGiandomenico has been the Chief of Transactions and director of MDB Capital Holdings, LLC since inception on August 10, 2021. Mr. DiGiandomenico has also served on the board of directors of ENDRA Life Sciences Inc. (Nasdaq: NDRA), a developer of enhanced ultrasound technology, from July 2013 until present, the board of directors of Provention Bio, Inc., a developer of multiple drug therapies, from January 2017 until May 2020 and the board of directors of Cue Biopharma, Inc., that develops novel biologic drugs for the selective modulation of the human immune system to treat a broad range of cancers and autoimmune disorders from January 2016 to October 2019. Since he co-founded Public Ventures (formerly known as MDB Capital Group, LLC) in 1997, Mr. DiGiandomenico has been enabling investment into early-stage disruptive technologies. He has worked alongside a wide range of companies in biotechnology, medical devices, high technology, and renewable energy spaces. Mr. DiGiandomenico holds an MBA from the Haas School of Business at the University of California, Berkeley and a BS in Finance from the University of Colorado. Mr. DiGiandomenico’ s extensive financial and investment banking expertise, general business acumen and significant executive leadership experience position him well to make valuable contributions to our board of directors.

James J. Lalonde. Dr. Lalonde has served as an independent director of the Company since April 1, 2024. Dr. Lalonde is a recognized leader in the field of synthetic biology and serves as an Scientific Advisor for several private start-up enterprises and since August 2023 has been the Chairman of the Board at Willow Biosciences Inc.  He previously served as Lead, Microbial Digital Genome Engineering Business with Inscripta Inc. from September 2019 to August 2021, a global leader in genome engineering technology, as Lead of its Microbial Digital Genome Engineering Business. Prior to that, from 2004 to 2019 Dr. Lalonde was Senior Vice President of R&D at Codexis, Inc., a leader in protein engineering. In his nearly 15 years at Codexis he oversaw development of more than 50 enzymes for drug manufacturing, nutrition, biotherapeutics, and molecular diagnostics. He also led development of the company’s pioneering CodeEvolver^® protein engineering technology which was licensed to major pharmaceutical companies. Prior to Codexis, Dr. Lalonde held leadership roles in biocatalysis and chemical development at Altus Biologics from 1993 to 2004 and in scientific research from 1989 to 1993 at Vista Chemical Company. He holds a bachelor’s degree in chemistry from Lakehead University (1983) and a Ph.D. in organic chemistry from Texas A&M University (1987).  He was a recipient of the US Presidential Green Chemistry Awards twice and was elected to the Academy of Distinguished Alumni at Texas A&M in 2022

Lon Edward Bell, PhD. Effective April 1, 2024 Dr. Bell joined the Board of Directors of the Company as an independent board member. Dr. Bell founded DTP Thermoelectrics LLC in 2021 and serves as its CEO. The company is focused on commercializing a new generation of solid-state heating, cooling and temperature control systems. Dr. Bell served as a board member from 2013 to 2016 and since 2017 has served as Chairman of CDTi Advanced Materials,Inc., a publicly traded company (CDTI: Pink Sheet). Dr Bell helped guide CDTI through a pivot to become an emerging developer of catalytic coating systems for the chemical reforming industry serving the emerging hydrogen economy and hydrocarbon sequestering industries. Since 2008 Dr. Bell has served as a member of the advisory board for the California Institute of Technology’s Department of Mechanical and Civil Engineering, serving as the Chair from 2015 to 2022. Dr Bell’s notable prior experiences include the founding of Amerigon (now Gentherm Incorporated, NASDAQ: THRM) in 1991, which has become a major supplier of solid-state thermal management systems to the automotive industry. Previously he founded Technar, Incorporated, in 1968, a pioneering supplier of automotive crash sensors to the automobile industry. He guided the company from its inception to its sale to TRW in 1991. Throughout his career, Dr. Bell has been granted over 100 patents for his inventions. Five clusters of his inventions have gone into mass production and achieved a significant share of their target markets. Dr. Bell has a bachelor’s degree in mathematics (1962), master’s degree in rocket propulsion (1963), and PhD in mechanical engineering (1968), from the California Institute of Technology. The Board believes that Dr. Bell’s educational attainments, management and leadership experience, entrepreneurial understanding and service on boards of other public companies, qualifies him to serve as a member of our Board.

Other Senior Officers

Michael Burns. Mr. Burns has served as Executive Vice President Energy Transition of the Company since September 2023. Prior to joining the Company, Mr. Burns held the position of Head of Biomass, Americas at Novozymes, North America Incorporated from September 2019 to September 2023. From June 2014 through September 2019 Mr. Burns held the position of Head of Biomass, North America at Novozymes, North America Incorporated. Mr. Burns also served as Director of Business and Commercial Development of Advanced Bio-Products for BP, Americas from 2012 through 2014. Mr. Burns received his Master of Business Administration from Western New England University in 1998 and a Bachelor of Science in Business Administration from Bryant University in 1989.

Zachary Karl, PhD. Dr. Karl has served as the Vice President and Head of Business Development for the Company since September 2023, spearheading the company’s growth trajectories and strategic partnerships in synthetic biology. Prior to joining the Company, Dr. Karl held the role of Director of Business Development at Ginkgo Bioworks from July 2022 to September 2023 where he cultivated strategic opportunities to expand the company’s synthetic biology outreach. Demonstrating his entrepreneurial acumen, he founded Ambedo in 2019 and later established TerraBite Farms in 2020, where he served as the Chief Executive Officer for both and helped to bridge termite biology with industrial innovation. His tenure at SAB Biotherapeutics from January 2021 to July 2022 saw him directing the development of a range of antigens, most notably for pathogens like COVID-19. Before this, at POET, LLC, Dr. Karl melded biochemistry research with business strategy from November 2014 to April 2020, championing innovation across diverse industry collaborations. Dr. Karl received his Ph.D. in Biochemistry and Molecular in 2013 from Purdue University and a Bachelor’s in Pre-Medicine and Microbiology from Wittenberg University in 2008.

Board Composition/Committees

Our board of directors currently consists of six persons. The board of directors may establish the number of persons serving on the board of directors from time to time by resolution. Currently, one of our directors, Messrs. Bowie, Lalonde, and Bell are independent directors within the meaning of Nasdaq’s rules. Mr. Bell is a “financial expert” as that term is defined in SEC regulations. The board of directors plans to add independent directors prior to completion of the offering to which this prospectus relates to satisfy the requirement of listing on a national exchange.

The board of directors will also establish various committees from time to time. It currently has the following committees: (i) audit committee, (ii) compensation committee, and (iii) nominations committee. The members of each committee are as follows: (i) audit committee – Messrs. Bowie, Lalonde, and Bell, (ii) compensation committee - Messrs. Bowie, Lalonde, and Bell, and (iii) nominations committee - Messrs. Bowie, Lalonde, and Bell. Each member of the above committees is an independent member of the board of directors.

Board Diversity

Each year the board of directors, will review the appropriate characteristics, skills, and experience required for the board of directors as a whole and its individual members. In evaluating the suitability of individual candidates, we will consider factors including, without limitation, an individual’s character, integrity, judgment, potential conflicts of interest, other commitments, and diversity. While we have no formal policy regarding board diversity for our board of directors as a whole nor for each individual member, our board of directors will consider such factors as gender, race, ethnicity and experience, area of expertise, as well as other individual attributes that contribute to the total diversity of viewpoints and experience represented on the board of directors.

The following is a table indicating the current board diversity, as of March 30, 2024

Audit Committee

We have established an audit committee. The audit committee will be responsible for, among other things: (i) retaining and overseeing our independent accountants; (ii) assisting the board of directors in its oversight of the integrity of our financial statements, the qualifications, independence and performance of our independent auditors; (iii) reviewing and approving the plan and scope of the internal and external audit; (iv) pre-approving any audit and non-audit services provided by our independent auditors; (v) approving the fees to be paid to our independent auditors; (vi) reviewing with our chief executive officer and chief financial officer (or chief accounting officer, as the case may be) and independent auditors the adequacy and effectiveness of our internal controls; (vii) reviewing hedging transactions; and (viii) reviewing and assessing annually the audit committee’s performance and the adequacy of its charter. The audit committee will also review and approve all transactions with affiliated parties. Our board of directors has adopted a written charter for the audit committee, which is available on our website.

Compensation Committee

We have established a compensation committee. The committee’s primary responsibilities include approving corporate goals and objectives relevant to executive officer compensation and evaluate executive officer performance in light of those goals and objectives, determining and approving executive officer compensation, including base salary and incentive awards, making recommendations to the board of directors regarding compensation plans, and administering our stock plan.

The compensation committee determines and approves all elements of executive officer compensation. It also provides recommendations to the board of directors with respect to non-employee director compensation. The compensation committee may not delegate its authority to any other person, other than to a subcommittee thereof.

The Company compensation policies for executive officers has two fundamental objectives: (i) to provide a competitive total compensation package that enables the Company to attract and retain highly qualified executives with the skills and experience required for the achievement of business goals; and (ii) to align certain compensation elements with the Company’s annual performance goals. With respect to each of the Company’s executive officers, the total compensation that may be awarded, including base salary, discretionary cash bonuses, annual stock incentive awards, stock options, restricted stock units and other equity awards, and other benefits and perquisites will be evaluated by the committee. Under certain circumstances, the committee may also award compensation payable upon termination of the executive officer under an employment agreement or severance agreement (if applicable). The Board recognizes that its overall goal is to award compensation that is reasonable when all elements of potential compensation are considered. The committee believes that cash compensation in the form of base salary and discretionary cash bonuses provides our executives with short-term rewards for success in operations, and that long-term compensation through the award of stock options, restricted stock units and other equity awards aligns the objectives of management with those of our stockholders with respect to long-term performance and success. The Board also has historically focused on the Company’s financial condition when making compensation decisions and approving performance objectives and compensation has been weighted more heavily toward equity-based compensation. The committee will continue to periodically reassess the appropriate weighting of cash and equity compensation in light of the Company’s expenditures in connection with commercial operations and its cash resources and working capital needs.

Nominating Committee

We have established a nominating committee. The committee’s primary responsibilities include identifying individuals qualified to serve on the board of directors and its committees, establishing procedures for evaluating the suitability of potential director nominees consistent with the criteria approved by the board of directors, reviewing the suitability for continued service as a director when his or her term expires and at such other times as the committee deems necessary or appropriate, and determining whether or not the director should be re-nominated, and reviewing the membership of the board of directors and its committees and recommending making changes, if any.

In evaluating director nominees, then nominating committee will generally consider the following factors:

There are no stated minimum criteria for director nominees, although the committee may consider such factors as it may deem are in the best interests of the Company and its stockholders. The nominating committee also believes it is appropriate for certain key members of our management to participate as members of the board of directors.

The nominating committee identifies nominees by first evaluating the current members of the board of directors willing to continue in service. Current members of the board of directors with skills and experience that are relevant to our business and who are willing to continue in service are considered for re-nomination, balancing the value of continuity of service by existing members of the board of directors with that of obtaining a new perspective. If any member of the board of directors does not wish to continue in service, or if the nominating committee decides not to re-nominate a member for re-election, the committee identifies the desired skills and experience of a prospective director nominee in light of the criteria above, or determines to reduce the size of the board of directors. Research may also be performed to identify qualified individuals. To date, we have not engaged third parties to identify or evaluate or assist in identifying potential nominees, nor do we anticipate doing so in the future.

Board’s Role in Risk Oversight

Our board of directors is primarily responsible for overseeing our risk management processes. Our board of directors, as a whole, determines our appropriate level of risk, assesses the specific risks that we face, and reviews management’s strategies for adequately mitigating and managing the identified risks. Although our board of directors administers this risk management oversight function, one or more committees of our board of directors may support our board of directors in discharging its obligations. For example, the audit committee reviews our major financial risk exposures and the steps management has taken to monitor and control such exposures and it will reviews matters relating to legal compliance that have a material effect on the Company financial statements and certain other limited areas of governance and will report to our board of directors regarding such matters.

Code of Business Conduct and Ethics

Our board of directors has adopted a code of business conduct and ethics that applies to all of our employees, officers, and directors. The full text of our code of business conduct and ethics will be posted on the Investor Relations section of our website. The reference to our website address in this prospectus does not include or incorporate by reference the information on our website into this prospectus. We intend to disclose future amendments to certain provisions of our code of business conduct and ethics, or waivers of these provisions, on our website or in public filings.

Clawback Policy

Our board of directors has adopted a written policy to recover “excess” compensation that is granted, earned, or vested based wholly or in part upon the attainment of a financial reporting measure. The compensation includes both cash-based and equity-based incentives. The compensation covered includes incentive awards awarded to any individuals (including former employees) who served as an executive officer during the three most recently completed fiscal years preceding the date on which the preparation of an accounting restatement is required, provided that the executive officers were awarded more incentive awards than they would have received if the financial statements had been prepared correctly. The recovery will include an executive incentive award even if the executive was not involved in preparing the financial statements or did not commit misconduct that led to the restatement. Restatements attributable to an inadvertent error also will subject executive officers to the recovery of previously received incentive awards.

Compensation of Members of Board of Directors

We do not intend to pay persons a director fee for serving on the board of directors who are also paid a salary or similar compensation by the Company. To the extent that we have any independent directors, the board of directors will determine their compensation at the time of their appointment and thereafter.

We do not have any defined compensation plans for our officers or directors. We may adopt one or more forms of compensation arrangements, including cash and stock-based compensation arrangements in the future. Any stock-based compensation plans will be subject to the approval of the holders of the shares of Common Stock as required by the listing rules of Nasdaq and any other applicable laws.

We also will reimburse any persons that are independent members of our board of directors for their reasonable expenses incurred in connection with attending meetings of our board of directors, committee meetings and other activities they undertake on our behalf and on behalf of our subsidiaries and partner companies.

Limitation of Liability of Directors and Indemnification of Directors and Officers

The Company provides indemnification to each person who was or is a party or is threatened to be made a party to or is involved in any threatened, pending, or completed action, suit, or proceeding, whether civil, criminal, administrative, or investigative by reason of the fact that he, or a person of whom he is the legal representative, is or was a director or officer or is or was serving at the request of the Company as a director or officer of another corporation or of a partnership, joint venture, trust, or other enterprise, including service with respect to employee benefit plans against all expenses, liability, and loss. The board of directors may authorize the advance of expenses in connection with any proceeding where the person is entitled to indemnification. The Company may purchase and maintain insurance to protect itself and any director, officer, employee or other agent against any expense, whether or not the Company would have the power to indemnify the person.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

Indemnification Agreements

We enter into indemnification agreements with each of the persons serving on the board of directors and executive officers. The indemnification agreements provide for indemnification against expenses, judgments, fines and penalties actually and reasonably incurred by an indemnitee in connection with threatened, pending or completed actions, suits or other proceedings, subject to certain limitations. The indemnification agreements also provide for the advancement of expenses in connection with a proceeding prior to a final, non-appealable judgment or other adjudication, provided that the indemnitee provides an undertaking to repay to us any amounts advanced if the indemnitee is ultimately found not to be entitled to indemnification by us. The indemnification agreement sets forth procedures for making and responding to a request for indemnification or advancement of expenses, as well as dispute resolution procedures that apply to any dispute between us and an indemnitee arising under the indemnification agreements.

EXECUTIVE COMPENSATION

This section provides an overview of the compensation awarded to, earned by, or paid to each individual who served as our principal executive officer and our next two most highly compensated executive officers in respect of their service to our company during the years ended December 31, 2021, 2022 and 2023. The amounts indicated for the year ending December 31, 2023, do not include any amounts that may be awarded as bonus compensation, as determined in 2024. We refer to these individuals as our named executive officers. The compensation information disclosed herein for our three named executive officers is disclosed in accordance with SEC requirements; such disclosure does not include the compensation for our other executive officers. Our named executive officers for the years ended December 31, 2021, 2022 and 2023 respectively, are as set forth in the table.

Equity Compensation

From time to time, in addition to the cash compensation, we grant equity based awards to our named executive officers, which are generally subject to vesting based on each of our named executive officer’s continued service with us.

Equity Incentive Plan

The Company adopted an equity incentive award plan, the 2020 Equity Incentive Award Plan, that permits it to grant directors, officers, employees and others that contribute to the success of the Company stock options, restricted stock, restricted share units, deferred stock and other equity-based awards. The ultimate value of these various awards is dependent on increases in our share of Common Stock price. Awards are granted to provide the holder of an award with a personal financial interest in our long-term success, encourage retention through vesting provisions and enable us to compete for the services of employees in an extremely competitive market and industry. Objectives of the long-term incentive portion of our compensation package includes aligning the personal and financial interests of management and other employees with shareholder interests; balancing short-term decision-making with a focus on improving shareholder value over the long-term; and providing a means to attract, reward and retain a skilled management team.

The 2020 Equity Incentive Award Plan provides for award grants of up to a base amount of 4,994,015 shares of Common Stock. As of December 31, 2023, there were 2,085,366 shares of Common Stock committed under awards subject to the plan. Shareholder approval is required for the plan to comply with certain IRS and Nasdaq requirements. Both the board of directors and shareholders have approved the plan.

The board of directors may grant awards under the plan for up to ten years from the date of plan adoption. The board of directors or a committee thereof will determine the form of award and its terms, such as the vesting period, the exercise period, any vesting criteria that might include performance goals and termination provisions. Typically, termination will be as a result of retirement, disability and the end of employment. Awards may not be issued at less than the fair market value of a share of Common Stock at the time of award. Although awards are typically exercised for a cash payment, the board of directors or applicable committee may issue the awards on a net exercise, or cashless, basis. Management makes recommendations to the board of directors or committee about the form of the award, the amount of the award levels and its terms. Management monitors overhang (a measure of potential earnings dilution from stock awards) as well as run rate (the rate at which stock awards are being awarded from our equity plans) when making recommendations to the board of directors or applicable committee regarding plan awards.

Currently, the plan is not registered under a Form S-8 registration statement. A Form S-8 registration statement for the plan can only be filed once the Company becomes a registrant under the Securities Act or the Exchange Act and meets the criteria for use of a registration statement that incorporates certain information by reference. Until registration, any share of Common Stock issued pursuant under the plan will be “restricted stock.”

Employment Agreement

Michael Heltzen, our Chief Executive Officer, is employed under an employment agreement, on an at-will basis.  Mr. Heltzen is paid an annual base salary of $250,000 and will be paid an annual bonus of up to 100% the amount of the then base salary. One third of the bonus is fully discretionary as determined by the board of directors and the balance is subject to meeting key performance indicators based on the overall performance of the Company and personal performance as determined annually by the board of directors in consultation with Mr. Heltzen. In addition, Mr. Heltzen initially was granted at the time of his initial employment an option to acquire up to 623,270 shares of common stock that vests over a five-year period, based on his continued employment with the Company as of the applicable vesting date, and on April 12, 2024 was granted a separate incentive option to acquire up to 44,194 shares of common stock which vest over a five year period, based on his continued employment with the Company as of the applicable vesting date.  Mr. Heltzen, and his family, will be entitled to participate in all of the Company’s executive benefit plans that may be established from time to time, including, without limitation, any 401(k) and cafeteria plans, health, hospitalization, medical insurance, dental and disability programs.  Mr. Heltzen will be reimbursed for ordinary business expenses. The employment can be terminated for cause, which is defined in the employment agreement, but if it is not terminated for cause, then the Company will pay a severance equal to nine months base salary and reimbursement for COBRA payments.  The agreement provides for typical indemnification for acts undertaken for the Company during the employment period.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

Related Party Transaction

During 2023, MDB Capital Holdings, LLC provided the financial services of its chief financial officer to the Company. The value of these services was determined to be $95,000, which was charged to operations. The amount remains unpaid as of December 31, 2023.

General Policy for Evaluating Related Party Transactions

Related party transactions will be reviewed by the audit committee, generally under its authority to review situations that give rise to conflicts of interest, as set forth in the audit committee charter. The policy of the Company is to evaluate those situations where an individual’s private interests interfere or conflict in any way (or even appear to interfere or conflict) with the interests of the Company. A common situation is one that involves a transaction between the Company and a party that is a director, officer or employee, or their respective related parties or affiliates or an entity under the control of those persons. The audit committee shall review the material facts of all related party transactions with the objective of determining to either approve or disapprove the Company entering into the transaction. The audit committee will review the relevant facts and circumstances of a related party transactions taking into account, among other factors, (i) whether the transaction was undertaken in the ordinary course of business of the Company, (ii) whether the related party transaction was initiated by the Company or the related party, (iii) whether the transaction is proposed to be, or was, entered into on terms no less favorable to the Company than terms that could have been reached with an unrelated third party, (iv) the purpose of, and the potential benefits to the Company of, the related party transaction, (v) the approximate dollar value and the terms of the obligations involved in the related party transaction, (vi) the extent of the related party’s interest in the transaction, and (vii) any other information that would be material to investors in light of the circumstances of the particular transaction. Approval may be a standing approval for the same types of transactions, where it is warranted. The audit committee may also ratify related party transactions that have occurred, but related parties are encouraged to seek prior approval of a transaction so as not to face the situation of having to unwind or modify it.

Parent Corporation

MDB Capital Holdings, LLC, is our parent company and the controlling shareholder before this offering, beneficially owning 62.88% of our shares of Common Stock. After this offering MDB Capital Holdings, LLC will beneficially own 47.48% of our common stock. If the over-allotment option is fully exercised by the underwriter of this offering, then MDB Capital Holdings, LLC will beneficially own 45.69% of our common stock.

Messrs. Christopher Marlett, Anthony DiGiandomenico are majority shareholders and directors of MDB, and directors of the Company. Mr. Mo Hayat, the Chairman of the Board and President of the Company, also is the Chief of Entrepreneurship & Operations of MDB.

PRINCIPAL SHAREHOLDERS

The following table sets forth information regarding the beneficial ownership of our Common Stock by:

Beneficial ownership is determined based on the rules and regulations of the SEC as defined in Rule 13d-3 of the Exchange Act. A person has beneficial ownership of a share of Common Stock if such individual has the power to vote and/or dispose of the shares. This power may be sole or shared and direct or indirect. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares that are subject to options or warrants held by that person and exercisable as of, or within 60 days of, the initial closing are counted as outstanding. These shares, however, are not counted as outstanding for the purposes of computing the percentage ownership of any other person(s). Except as may be indicated in the footnotes to this table and pursuant to applicable community property laws, each person named in the table has sole voting and dispositive power with respect to the number of shares of Common Stock set forth opposite that person’s name. Unless indicated below, the address of each individual listed below is c/o Invizyne Technologies Inc., 750 Royal Oaks Drive, Suite 106, Monrovia, CA 91016.

Applicable percentage ownership in the following table is based on 12,500,000 shares of Common Stock outstanding as of March 31, 2024, which amount of shares reflects the stock dividend declared February 7, 2024 at the rate of 1.0775673 for each issued and outstanding share of Common Stock.

* Less than 0.1%

(1) Beneficial ownership has been determined in accordance with Rule 13d-3 under the Exchange Act.

(2) Based on a total of 12,5000,000 shares of Common Stock issued and outstanding as of March 31, 2024, as adjusted for the share dividend of 1.0775673 per share of Common Stock.

(3) Based on a total of 17,050,000 shares of Common Stock issued and outstanding as of March 31, 2024, as adjusted for the share dividend of 1.0775673 per share of Common Stock, and assuming the sale of 4,300,000 shares of Common Stock in the initial public offering and the automatic conversion of the outstanding SAFE securities for 250,000 shares of Common Stock.

(4) Includes (i) 7,616,952 issued and outstanding shares of Common Stock held prior to the initial public offering, (ii) 245,313 shares of Common Stock to be issued on conversion of the SAFE security on the completion of the offering, and (iii) 410,586 shares of Common Stock underlying a previously issued warrant, all of which 8,272,851 shares of Common Stock are held by MDB Capital Holdings, LLC over which the individual has voting and dispositive authority, and also includes (iv) 30,298 shares subject to currently exercisable options. (See footnote 12.)

(5) Includes 155,818 issued and outstanding shares of Common Stock held prior to the initial public offering, and 363,575 shares subject to currently exercisable options. Excludes 369,529 shares subject to restricted stock units that vest in the future and 259,696 shares subject to options that vest in the future. Excludes shares held by MDB Capital Holdings, LLC, because the individual does not have voting or dispositive authority over those shares.

(6) Includes 1,155,820 issued and outstanding shares held prior to the initial public offering and 30,298 shares subject to currently exercisable options and excludes 21,642 shares subject to options that vest in the future.

(7) Excludes 667,464 shares subject to options that vest in the future.

(8) Excludes 83,103 shares subject to options that vest in the future.

(9) Includes 1,444,602 issued and outstanding shares held prior to the initial public offering and 48,476 shares subject to currently exercisable options. Excludes 158,208 shares subject to restricted stock units that vest in the future and 34,627 shares subject to options that vest in the future.

(10) Includes 1,276,319 issued and outstanding shares held prior to the initial public offering and 45,447 shares subject to currently exercisable options. Excludes 149,224 shares subject to restricted stock units that vest in the future and 32,462 shares subject to options that vest in the future.

(11) See footnotes 4 - 10 above.

(12) Includes (i) 7,616,952 issued and outstanding shares of Common Stock held prior to the initial public offering, (ii) 245,313 shares of Common Stock to be issued on conversion of the SAFE security on the completion of the offering, and (iii) 410,586 shares of Common Stock underlying a previously issued warrant, all of which 8,272,851 shares of Common Stock are held by MDB Capital Holdings, LLC. Messrs. Christopher A. Marlett and Anthony DiGiandomenico have the voting and dispostive authority over the shares of Common Stock of Invizine. The address of MDB Capital Holdings, LLC, and the business address of Messrs. Marlett and DiGiandomenico is 14135 Midway Road, Suite G-150, Addison, TX 75001.

DESCRIPTION OF CAPITAL

General

The following is a summary of information concerning capital stock of the Company and the securities we are offering. The summaries and descriptions below do not purport to be complete statements of the relevant provisions of the Company’s articles of incorporation, as amended, amended and restated by-laws, all of which are entirely qualified by these documents.

Common Stock

Our articles of incorporation currently authorize us to issue up to 50,000,000 shares of Common Stock, $0.000001 par value. Immediately prior to the date of this prospectus, there were 12,500,000 shares of Common Stock issued and outstanding, which amount reflects the stock dividend of an aggregate of 6,483,351 shares of Common Stock issued as of February 7, 2024, at the rate of 1.0775673 for each issued and outstanding share of Common Stock.

Subject to prior dividend rights of the holders of any shares of issued and outstanding preferred stock of the Company, holders of shares of Common Stock are entitled to receive dividends when, as and if declared by the Board out of funds legally available for that purpose.

Each share of Common Stock is entitled to one vote on all matters submitted to a vote of stockholders. Holders of shares of Common Stock do not have cumulative voting rights. The holders of a majority of the shares of Common Stock present and entitled to vote in the election of directors can elect all directors standing for election.

In the event of any liquidation, dissolution or winding up of the Company, after the satisfaction in full of the liquidation preferences of holders of any shares of issued and outstanding preferred stock, holders of shares of Common Stock are entitled to ratable distribution of the remaining assets available for distribution to stockholders. The shares of Common Stock are not subject to redemption by operation of a sinking fund or otherwise. Holders of shares of Common Stock are not entitled to pre-emptive rights.

The issued and outstanding shares of Common Stock are fully paid and non-assessable. Any additional shares of Common Stock that the Company may issue in the future will also be fully paid and non-assessable.

Preferred Stock

Our articles of incorporation authorize us to issue up to 5,000,000 shares of undesignated preferred stock, par value $0.001 per share. We may issue preferred stock from time to time in one or more series, without shareholder approval, when authorized by our board of directors. No shares of preferred stock are issued or are outstanding.

The specific terms of any series of preferred stock will be governed by our articles of incorporation and by the certificate of designations relating to that series. The board of directors has the right, without prior approval of the holders of Common Stock, subject to any rights of currently issued preferred stock, to specify any and all terms of a series of preferred stock, including the rank, dividend and distribution rights, voting rights, liquidation rights and redemption, conversion and preemption rights. The issuance of preferred stock could have the effect of restricting dividends on our Common Stock, diluting the voting power of our Common Stock, impairing the liquidation rights of our Common Stock, or delaying or preventing a change in control of us, all without further action by our stockholders.

SAFE

A SAFE (Simple Agreement for Future Equity) is an agreement to provide an investor a future equity stake in the issuing company based on the amount invested if, and only if, a triggering event occurs, such as an additional round of financing or the sale of the company. The Company received a commitment for funding of two SAFEs on July 3, 2023, for a cash payment from the investors in the aggregate amount of $800,000. One SAFE was issued to MDB Capital Holding, LLC in the aggregate amount of $785,000. The pre-money valuation cap was two hundred million dollars, The discount rate was 80%. The SAFE will convert into the next round equity financing that results in gross proceeds of not less than $5,000,000 to the Company, and also in the event of a change of control, direct listing and an initial public offering. It is also entitled to receive a portion of the proceeds of any liquidation or dissolution event, as these are defined in the SAFE instrument. The SAFE securities will convert into approximately 250,000 shares of Common Stock as a result of the offering to which this prospectus relates, based on a per share price of $3.20 under the terms of the SAFE. The shares will be issued at the closing of this offering, as restricted stock, and they will be subject to resale provisions of Rule 144 and a selling security holder prospectus included in the registration statement to which this prospectus relates. The shares do not have any mandatory registration rights.

Warrant – MDB Capital Holdings, LLC

In connection with the initial capitalization of the Company by MDB Capital Holdings, LLC in the aggregate amount of $5,000,000, which was funded during the period July 2, 2019 to June 22, 2022, MDB Capital Holdings, LLC was issued on June 22, 2022, a warrant to purchase up to 410,586 shares of Common Stock, at an exercise price of $1.22 until June 22, 2027. The warrant may be exercised for cash or on a cashless exercise basis. The warrant includes anti-dilution provisions, certain rights on a change of control of the Company, and the ability to purchase shares of Common Stock on the same terms as those provided to shareholders of the Company by reason of a right or similar purchase privilege on the same terms thereof, which would include the rights being distributed to the shareholders of the Company the exercise of which is the subject of this prospectus. The warrant holder is not a shareholder and has none of the rights of a shareholder until the warrant is exercised and the shares of Common Stock are issued upon exercise. Upon exercise of the warrant, the shares of Common Stock to be issued will be issued as restricted stock as that term is defined in the Securities Act. The shares of Common Stock issuable upon exercise of the warrant are subject to the registration rights agreement to which MDB Capital Holdings, LLC is a party, dated April 17, 2019.

Registration Rights

The Company entered into a registration rights agreement with the founders and MDB Capital Holdings, LLC at the time of the MDB investment on April 17, 2019. Under the agreement, (i) after the Company becomes subject to the periodic reporting obligations under the Exchange Act, and (ii) any restriction period has expired, if there is not an effective registration statement covering the securities identified as Registrable Securities (defined in the registration rights agreement), then if the Company prepares and files with the SEC a registration statement relating to an offering for its own account or the account of others, the Company shall promptly send to the holders of the Registrable Securities a written notice of the anticipated registration and those holders may have their Registrable Securities included in the registration statement for resale. In addition, on the first registration statement after the Company has become a reporting company under the Exchange Act, to the extent the registration statement may be used for this purpose, the Company will register all the Registrable Securities of the holder, as requested, subject to certain cutback provisions and a follow up registration obligation of the Company for any Registrable Securities not so registered. The agreement also provides for three demand registration rights, with limits on the frequency of the exercise of the demand and whether the Company is eligible for use of a Form S-1 or Form S-3 registration statement. The registration rights agreement provides for typical securities indemnification to the holders in respect of the registration statement. Notwithstanding the terms of the agreement, the Company has registered various securities on behalf of MDB Capital Holdings, LLC under a resale prospectus included in the registration statement to which this prospectus relates.

Authorized but Unissued Shares

The authorized but unissued shares of our Common Stock are available for future issuance without shareholder approval, subject to any limitations imposed by the listing standards of The Nasdaq Capital Market and Nevada law, which require shareholder approval if the issuance will result in a change of control or the number of shares is in excess of 20% of the then outstanding shares. These additional authorized shares may be used for a variety of corporate finance transactions, acquisitions and employee benefit plans, as determined by the board of directors. The existence of authorized but unissued and unreserved Common Stock and preferred stock could make more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.

Anti-takeover provisions

We are governed by the provisions of Nevada Revised Statutes 78.378 to 78.3793 because we are incorporated in Nevada. These provisions prohibit a person who owns in excess of ten percent (10%) of our outstanding voting stock from merging, consolidating or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of ten percent (10%) of our outstanding voting stock, unless the merger, consolidation or combination is approved in a prescribed manner. Any provision in our Articles of Incorporation or our Bylaws or Nevada law that has the effect of delaying or deterring a change in control could limit the opportunity for our Shareholders to receive a premium for their shares of our Common Stock and could also affect the price that some investors are willing to pay for our Common Stock.

Limitation of Liability and Indemnification of Directors and Officers

Our articles of incorporation and bylaws provide that our directors and officers will be indemnified by us to the fullest extent authorized by Nevada law as it now exists or may in the future be amended, against all expenses and liabilities reasonably incurred in connection with their service for or on our behalf. In addition, our articles of incorporation provides that our directors will not be personally liable for monetary damages to us for breaches of their fiduciary duty as directors, except for liability (i) for any appropriation by a director, in violation of his or her duties, of any business opportunity of the Company, (ii) for acts or omissions which involve intentional misconduct or a knowing violation of the law, (iii) with respect to illegal dividends or redemptions, or (iv) for any transaction from which the director received an improper personal benefit. Our bylaws also permit us to secure insurance on behalf of any officer, director or employee for any liability arising out of his or her actions, regardless of whether Nevada law would permit indemnification.

These provisions may discourage stockholders from bringing a lawsuit against our directors for breach of their fiduciary duty. These provisions also may have the effect of reducing the likelihood of derivative litigation against directors and officers, even though such an action, if successful, might otherwise benefit us and our stockholders. Furthermore, a stockholder’s investment may be adversely affected to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions. We believe that these provisions, insurance and the indemnity agreements are necessary to attract and retain talented and experienced directors and officers.

There is no pending litigation or proceeding involving any of our directors or officers where indemnification by us would be required or permitted. We are not aware of any threatened litigation or proceeding that might result in a claim for such indemnification. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

Transfer Agent and Registrar

The transfer agent and registrar for the shares of Common Stock issued by the Company is VStock Transfer, LLC, 18 Lafayette Place, Woodmere, NY 11598, with a general telephone number of 212-828-8436 and a general email of info@vstocktransfer.com.

UNDERWRITING (CONFLICTS OF INTEREST)

 We have entered into an underwriting agreement, dated [___], 2024, with Public Ventures, LLC, acting as the sole book-running manager. Subject to the terms and conditions of the underwriting agreement, the underwriter named below has agreed to purchase, and we have agreed to sell to it, the number of shares of Common Stock listed next to its name at the public offering price, less the underwriting discounts and commissions, as set forth on the cover page of this prospectus and as indicated below:

The underwriting agreement provides that the obligations of the underwriter to pay for and accept delivery of the shares of Common Stock offered by this prospectus are subject to various conditions and representations and warranties, including the approval of certain legal matters by its counsel and other conditions specified in the underwriting agreement. The shares of Common Stock are offered by the underwriter, subject to prior sale, when, as and if issued to and accepted by the underwriter. The underwriter reserves the right to withdraw, cancel or modify the offer to the public and to reject orders in whole or in part. The underwriter is obligated to take and pay for all of the shares of Common Stock offered by this prospectus if any such shares are taken.

The underwriter, in its sale of the shares being purchased from the Company, intends to give preference to holders of MDB Class A Shares, after which it will give preference to other beneficial shareholders of MDB and then beneficial shareholders of the Company. The underwriter does not have any information at this time as to the number of shares of Common Stock that any of these foregoing groups of potential investors may purchase. To the extent these foregoing groups do not purchase all the available shares, including the overallotment, then shares will be sold to other persons making an indication for purchase of shares through their respective brokers or dealers.

We have agreed to indemnify the underwriter and certain of its affiliates and controlling persons (within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act), among others, against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the underwriter may be required to make in respect thereof.

Discounts and Commissions

The underwriter proposes to offer the shares of Common Stock directly to the public at the public offering price set forth on the cover page of this prospectus. After the offering to the public, the offering price and other selling terms may be changed by the underwriter without changing the proceeds we will receive from the underwriter. Any shares sold by the underwriter to securities dealers will be sold at the public offering price less a selling concession not in excess of $0.20 per share, the full amount of the commissions and discount. The underwriter has also informed the Company that it will assign up to all the underwriter warrants to selected dealers and other persons as permitted by FINRA regulation.

The following table summarizes the public offering price, underwriting commissions and proceeds before expenses to us. The underwriting commission is 5% of the public offering price.